Scheduled In-house

Medical Devices Training Courses

The constant development of new medical devices, alongside changes and updates to regulations are paramount to this ever-changing and highly diverse field. Whether you are looking to develop your understanding of combination products, dry powder inhalers, FDA processes or would like to learn about how to write and edit medical writings, IPI Academy offers a wide selection of medical device industry training courses for you to keep up with and understand the changes and specialities of Medical Devices.

With over a hundred expert speakers, we deliver training that is highly interactive and offers a great opportunity for you to network with others working in the medical device industry. Find the medical device training course that best suits your needs or contact us to find out more.

  • Next: 3-4 Oct 2022 Live online

Medical Device Studies: Regulatory Requirements and Adverse Event Reporting

Live online
Focused

An essential overview of medical device clinical evaluations, clinical investigations, post-market clinical follow-up requirements and adverse event and vigilance reporting.

  • 12 CPD hours
  • Presented by Ms Janette Benaddi
  • Next: 4-5 Oct 2022 Live online

An Introduction to the Design and Development of Medical Devices

Live online
Focused

A comprehensive introduction to the design and development of medical devices, including device constituent parts of combination products

  • 12 CPD hours
  • Presented by Mr David Howlett
  • Next: 11 Oct 2022 Live online

Cyber Security for Medical Devices

Live online
Focused

The impact of Cyber Security incidents on society is high, and in critical infrastructures such as healthcare it impacts the ability for hospitals to provide care. Cybersecurity for medical devices is not just about safety, it should also protect the confidentiality, integrity and availability of systems and data. This seminar will provide you with an understanding of cybersecurity and its increasing regulatory focus, and how to embed and apply state-of-the-art security in your existing processes to deliver safe and secure products and solutions.

  • 6 CPD hours
  • Presented by Mr Ben Kokx
  • Next: 18-21 Oct 2022 Live online

Medical Device Software: Complying with the EU MDR, EU IVDR & FDA Regulations

Live online
Focused

An introduction to medical device software regulations and requirements to include the latest EU and FDA guidance and risk management.

  • 24 CPD hours
  • Presented by Mr Koen Cobbaert
  • and Mrs Zuzanna Kwade
  • Next: 19-20 Oct 2022 Live online

Medical Writing for Medical Devices

Live online
Focused

How to produce quality regulatory documents including the clinical evaluation report (CER)

  • 12 CPD hours
  • Presented by Ms Barbara Grossman
  • and Ms Janette Benaddi
  • Next: 3-4 Nov 2022 Live online

Introduction to the In-Vitro Diagnostic Regulation (IVDR)

Live online
Focused

This two-day seminar will clarify the requirements applicable to in-vitro diagnostic devices under the IVD Regulation (EU) 2017/746. It will highlight the major changes to responsibility and product data expectations and will review the impact to industry.

  • 12 CPD hours
  • Presented by Nancy Consterdine
  • and Stuart Angell
  • Next: 3 Nov 2022 Live online

UK Conformity Assessed (UKCA) Marking for Medical Devices

New for 2022

Live online
Focused

With the June 2023 UKCA mark deadline rapidly approaching, the challenges facing Medical Device companies, Regulators and Conformity Assessment Bodies are growing. The requirements for this new UKCA mark will impact technical documentation, labelling, logistics and regulatory compliance. The steps you need to take to prepare for the UKCA marking will depend on the current status of your business and your future market access requirements. This seminar will provide UK and global companies practical guidance on what you need to do to continue market access or gain market access with your medical device in the UK after June 2023.

  • 6 CPD hours
  • Presented by Ms Janette Benaddi
  • Next: 7 Nov 2022 Live online

Drug/Device and Device/Drug Combinations in the EU and USA

Live online
Focused

Practical guidance on borderline Issues and combination products

  • 12 CPD hours
  • Presented by Dr David Jefferys
  • + 3 more
  • Next: 8-10 Nov 2022 Live online

An Introduction to the Medical Device Regulation

Live online
Focused

This seminar provides a detailed introduction to the European medical device legislation. It will explain the Regulation and which products are covered, the involvement of Notified Bodies, how to choose one and outline what a manufacturer must do.

  • 18 CPD hours
  • Presented by Ms Janette Benaddi
  • + 2 more
  • Next: 8 Nov 2022 Live online

EU Artificial Intelligence (AI) Act and its Impact on Medical Device Manufacturers

New for 2022

Live online
Focused

Many companies take part in the global ‘race to AI’ by continuously broadening the role of AI in their product portfolio. However, the rules of the game appear to be changing. The increased visibility of the technology’s risks has led to calls for regulators to look beyond the benefits, and also secure appropriate legislation to ensure AI that is ‘trustworthy’– legal, ethical, and robust. During this session, we will discuss the main players, trends, and challenges in the ‘race’ to AI regulation and how companies can move forward with an advantage.

  • 3 CPD hours
  • Presented by Mr Koen Cobbaert
  • Next: 10 Nov 2022 Live online

Drug/Device and Device/Drug Combinations in the EU and USA

Live online
Focused

Practical guidance on borderline Issues and combination products

  • 12 CPD hours
  • Presented by Dr David Jefferys
  • + 3 more
  • Next: 24-25 Nov 2022 Live online

Medical Device Studies: Clinical Evidence

Live online
Focused

Gathering and using clinical evidence for CE marking and post-market compliance in line with the new MDR

  • 12 CPD hours
  • Presented by Ms Janette Benaddi
  • Next: 28-29 Nov 2022 Live online

Clinical Evaluation of Medical Devices: The Clinical Evaluation Report

Live online
Focused

Cover all the aspects of clinical evaluation in line with the European medical device regulations and applicable guidance documents

  • 12 CPD hours
  • Presented by Ms Janette Benaddi
  • Next: 1-2 Dec 2022 Classroom

Medical Device Single Audit Programme (MDSAP)

New for 2022

Classroom
Focused

The Medical Device Single Audit Program (MDSAP) was developed by the International Medical Device Regulators Forum (IMDRF) to conduct regulatory audits of the quality management systems (QMS) used by manufacturers of medical devices. This course will prepare you to host a MDSAP audit within your organisation, and allow you to determine if your own internal QMS processes are consistent with requirements of the MDSAP for the jurisdictions where your products are marketed, or for those markets which you are planning to access.

  • 12 CPD hours
  • Presented by Dr Eamonn Hoxey
  • Next: 5-9 Dec 2022 Live online

The Medical Device School - From Concept to CE Marking

Live online
Intensive

This comprehensive course has been designed to map the processes from device concept to marketing and show how regulatory, quality, clinical and other aspects of device development are joined into a continuous process.

  • 30 CPD hours
  • Presented by Adrian Keene
  • + 7 more
  • Next: 5-6 Dec 2022 Classroom

FDA Approval Process for Medical Devices

Classroom
Focused

This seminar will provide a solid foundation in the approval and clearance processes for medical devices in the United States including the underlying legal and regulatory requirements and the 'general controls' applicable to all devices.

  • 12 CPD hours
  • Presented by Dr Jonathan Hughes
  • Next: 7-8 Dec 2022 Classroom

Human Factors and Usability Engineering in the Development of Drug Delivery Products

Classroom
Focused

Applying HF and usability to comply with the MDR. This two-day workshop has been designed specifically for product developers who want to incorporate human factors testing into their product development, or need to provide the regulators with specific usability data for their device.

  • 12 CPD hours
  • Presented by Mr Richard Featherstone
  • Next: 7-8 Dec 2022 Live online

Medical Device Regulations in the Middle East and North Africa

Live online
Focused

This seminar will provide an essential overview of the key areas of requirements for product approvals for medical devices in the Middle East and North Africa. Covering Algeria, Bahrain, Egypt, Israel, Iran, Iraq, Jordan, Kuwait, Lebanon, Libya, Morocco, Oman, Palestine, Saudi Arabia, Sudan, Syria, Tunisia, UAE and Yemen

  • 12 CPD hours
  • Presented by Ms Ilona Putz
  • and Ms Heba Hashem
  • Next: 14-15 Dec 2022 Classroom

Drug/Device and Device/Drug Combinations in the EU and USA

Classroom
Focused

Practical guidance on borderline Issues and combination products

  • 12 CPD hours
  • Presented by Dr David Jefferys
  • + 3 more
  • Next: 18-19 Jan 2023 Live online

Medical Device Studies: Regulatory Requirements and Adverse Event Reporting

Live online
Focused

An essential overview of medical device clinical evaluations, clinical investigations, post-market clinical follow-up requirements and adverse event and vigilance reporting.

  • 12 CPD hours
  • Presented by Ms Janette Benaddi
  • Next: 20 Jan 2023 Live online

Cyber Security for Medical Devices

Live online
Focused

The impact of Cyber Security incidents on society is high, and in critical infrastructures such as healthcare it impacts the ability for hospitals to provide care. Cybersecurity for medical devices is not just about safety, it should also protect the confidentiality, integrity and availability of systems and data. This seminar will provide you with an understanding of cybersecurity and its increasing regulatory focus, and how to embed and apply state-of-the-art security in your existing processes to deliver safe and secure products and solutions.

  • 6 CPD hours
  • Presented by Mr Ben Kokx
  • Next: 24 Jan 2023 Live online

Sustainable Design and Manufacture for Medical Devices

New for 2023

Live online
Focused

Sustainability in medical technology, as in all industries, is increasingly no longer an option. It’s not a question of “if” – it’s a question of “how”. This seminar will give you an in depth understanding of what sustainability options exist, what the benefits are, what drives them, and how to choose which will work for your company. It will also provide practical advice on how to implement change.

  • 6 CPD hours
  • Presented by Cormac O'Prey
  • Next: 26 Jan 2023 Live online

Quality Management Refresher

New for 2023

Live online
Focused

This seminar has been designed to provide a highly interactive session to refresh key personnel in the principles and practices of Quality Management and bring them up-to-date with the latest legal requirements. The seminar will review the key elements of the Pharmaceutical Quality System (PQS) and the roles and responsibilities of all staff involved in the PQS, including management. It will also provide a comprehensive overview of the essential principles and requirements of "The Orange Guide” and other relevant regulatory requirements.

  • 6 CPD hours
  • Presented by Rob Hughes
  • Next: 2-3 Feb 2023 Live online

Advanced Regulatory Affairs for Medical Devices

Live online
Focused

Planning your regulatory strategy to comply with the Medical Device Regulation (MDR)

  • 12 CPD hours
  • Presented by Ms Janette Benaddi
  • and Ms Theresa Jeary
  • Next: 2-3 Feb 2023 Classroom

Sterilization of Medical Devices

New for 2023

Classroom
Focused

Sterile devices are free of viable microorganisms and sterilization is one of the key processes in the production of sterile medical devices. Regulations for medical devices include particular requirements for devices supplied or intended to be used in a sterile state. These regulatory requirements relate to general safety and performance aspects for the products, and the requirements for independent, third-party conformity assessment of the processes for achieving sterility. Evidence of successful sterilization is important and expected when demonstrating conformity with the regulations. This course provides a comprehensive overview of these regulatory requirements and how to comply, together with the science and standards that support them.

  • 12 CPD hours
  • Presented by Dr Eamonn Hoxey
  • Next: 6-7 Feb 2023 Live online

Medical Device Regulations in the Middle East and North Africa

Live online
Focused

This seminar will provide an essential overview of the key areas of requirements for product approvals for medical devices in the Middle East and North Africa. Covering Algeria, Bahrain, Egypt, Israel, Iran, Iraq, Jordan, Kuwait, Lebanon, Libya, Morocco, Oman, Palestine, Saudi Arabia, Sudan, Syria, Tunisia, UAE and Yemen

  • 12 CPD hours
  • Presented by Ms Ilona Putz
  • and Ms Heba Hashem
  • Next: 7-9 Feb 2023 Live online

An Introduction to the Medical Device Regulation

Live online
Focused

This seminar provides a detailed introduction to the European medical device legislation. It will explain the Regulation and which products are covered, the involvement of Notified Bodies, how to choose one and outline what a manufacturer must do.

  • 18 CPD hours
  • Presented by Ms Janette Benaddi
  • + 2 more
  • Next: 21-24 Feb 2023 Live online

New Regulations for Medical Devices and IVDs in Europe

Live online
Focused

During a period of change and opportunity within the medical technology and diagnostics sectors, this seminar will help you prepare and operate successfully in Europe and the UK post Brexit.

  • 12 CPD hours
  • Presented by Dr David Jefferys
  • + 2 more
  • Next: 27 Feb-2 Mar 2023 Live online

Clinical Evaluation of Medical Devices: The Clinical Evaluation Report

Live online
Focused

Cover all the aspects of clinical evaluation in line with the European medical device regulations and applicable guidance documents

  • 12 CPD hours
  • Presented by Ms Janette Benaddi
  • Next: 1 Mar 2023 Live online

EU Artificial Intelligence (AI) Act and its Impact on Medical Device Manufacturers

Live online
Focused

Many companies take part in the global ‘race to AI’ by continuously broadening the role of AI in their product portfolio. However, the rules of the game appear to be changing. The increased visibility of the technology’s risks has led to calls for regulators to look beyond the benefits, and also secure appropriate legislation to ensure AI that is ‘trustworthy’– legal, ethical, and robust. During this session, we will discuss the main players, trends, and challenges in the ‘race’ to AI regulation and how companies can move forward with an advantage.

  • 3 CPD hours
  • Presented by Mr Koen Cobbaert
  • Next: 3 Mar 2023 Live online

UK Conformity Assessed (UKCA) Marking for Medical Devices

Live online
Focused

With the June 2023 UKCA mark deadline rapidly approaching, the challenges facing Medical Device companies, Regulators and Conformity Assessment Bodies are growing. The requirements for this new UKCA mark will impact technical documentation, labelling, logistics and regulatory compliance. The steps you need to take to prepare for the UKCA marking will depend on the current status of your business and your future market access requirements. This seminar will provide UK and global companies practical guidance on what you need to do to continue market access or gain market access with your medical device in the UK after June 2023.

  • 6 CPD hours
  • Presented by Ms Janette Benaddi
  • Next: 7-8 Mar 2023 Classroom

Human Factors and Usability Engineering in the Development of Drug Delivery Products

Classroom
Focused

Applying HF and usability to comply with the MDR. This two-day workshop has been designed specifically for product developers who want to incorporate human factors testing into their product development, or need to provide the regulators with specific usability data for their device.

  • 12 CPD hours
  • Presented by Mr Richard Featherstone
  • Next: 9-10 Mar 2023 Live online

Introduction to the In-Vitro Diagnostic Regulation (IVDR)

Live online
Focused

This two-day seminar will clarify the requirements applicable to in-vitro diagnostic devices under the IVD Regulation (EU) 2017/746. It will highlight the major changes to responsibility and product data expectations and will review the impact to industry.

  • 12 CPD hours
  • Presented by Nancy Consterdine
  • and Stuart Angell
  • Next: 15-16 Mar 2023 Live online

Medical Writing for Medical Devices

Live online
Focused

How to produce quality regulatory documents including the clinical evaluation report (CER)

  • 12 CPD hours
  • Presented by Ms Barbara Grossman
  • and Ms Janette Benaddi
  • Next: 16 Mar 2023 Live online

Smart Packaging and Electronic Patient Information

New for 2023

Live online
Focused

Increased use of SMART technologies has become ever more prevalent in the delivery of healthcare solutions as well as in the electronic delivery of Patient Information (e-PIL) and leaflets (e-leaflets). This course will provide an overview of the current technologies, the patient and societal benefits and some building blocks for the establishment and delivery of e-PIL and SMART strategic initiatives, providing insight as to where organisations may be most significantly impacted.

  • 6 CPD hours
  • Presented by Mr Christopher Waterhouse
  • Next: 20-23 Mar 2023 Live online

Medical Device Studies: Clinical Evidence

Live online
Focused

Gathering and using clinical evidence for CE marking and post-market compliance in line with the new MDR

  • 12 CPD hours
  • Presented by Ms Janette Benaddi
  • Next: 21-24 Mar 2023 Live online

FDA Approval Process for Medical Devices

Live online
Focused

This seminar will provide a solid foundation in the approval and clearance processes for medical devices in the United States including the underlying legal and regulatory requirements and the 'general controls' applicable to all devices.

  • 12 CPD hours
  • Presented by Dr Jonathan Hughes
  • Next: 23-24 Mar 2023 Classroom

Biological Evaluation of Medical Devices

Classroom
Focused

Key guidance on how to use the ISO 10993 series of standards and successfully apply a risk management approach to the biological evaluation of medical devices. *Includes:* Interactive workshops and discussion sessions

  • 12 CPD hours
  • Presented by Mr Philip Clay
  • and Rona Middlemiss
  • Next: 23-24 Mar 2023 Live online

Medical Device Single Audit Programme (MDSAP)

Live online
Focused

The Medical Device Single Audit Program (MDSAP) was developed by the International Medical Device Regulators Forum (IMDRF) to conduct regulatory audits of the quality management systems (QMS) used by manufacturers of medical devices. This course will prepare you to host a MDSAP audit within your organisation, and allow you to determine if your own internal QMS processes are consistent with requirements of the MDSAP for the jurisdictions where your products are marketed, or for those markets which you are planning to access.

  • 12 CPD hours
  • Presented by Dr Eamonn Hoxey
  • Next: 27-30 Mar 2023 Live online

Metered Dose Inhaler (MDI) Technology

Live online
Focused

A comprehensive overview of MDIs including development, manufacture, regulation and market potential

  • 12 CPD hours
  • Presented by Mr David Howlett
  • Next: 30 Mar 2023 Live online

Pre-Filled Syringes: End-to-End Processing

Live online
Focused

Topics such as quality of syringe manufacture, quality of syringe components and why, quality of filling (volume check, reject reduction), quality of inspection and product release will be discussed in detail.

  • 6 CPD hours
  • Presented by Andreas Rothmund
  • and Dr. Dale Charlton
  • Next: 18-21 Apr 2023 Live online

Medical Device Regulation in the Eurasion Union, Russia and the CIS

Live online
Focused

A comprehensive overview of medical device regulatory affairs in Russia and the Eurasian Union. Key countries covered include Armenia, Azerbaijan, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, Turkmenistan and Ukraine.

  • 12 CPD hours
  • Presented by Mrs Anna Harrington-Morozova
  • Next: 24-27 Apr 2023 Live online

Medical Device Software: Complying with the EU MDR, EU IVDR & FDA Regulations

Live online
Focused

An introduction to medical device software regulations and requirements to include the latest EU and FDA guidance and risk management.

  • 24 CPD hours
  • Presented by Mr Koen Cobbaert
  • and Mrs Zuzanna Kwade
  • Next: 24-27 Apr 2023 Live online

An Introduction to the Design and Development of Medical Devices

Live online
Focused

A comprehensive introduction to the design and development of medical devices, including device constituent parts of combination products

  • 12 CPD hours
  • Presented by Mr David Howlett
  • Next: 27-28 Apr 2023 Live online

Sustainable Design and Manufacture for Medical Devices

New for 2023

Live online
Focused

Sustainability in medical technology, as in all industries, is increasingly no longer an option. It’s not a question of “if” – it’s a question of “how”. This seminar will give you an in depth understanding of what sustainability options exist, what the benefits are, what drives them, and how to choose which will work for your company. It will also provide practical advice on how to implement change.

  • 6 CPD hours
  • Presented by Cormac O'Prey
  • Next: 28 Apr 2023 Live online

Cyber Security for Medical Devices

Live online
Focused

The impact of Cyber Security incidents on society is high, and in critical infrastructures such as healthcare it impacts the ability for hospitals to provide care. Cybersecurity for medical devices is not just about safety, it should also protect the confidentiality, integrity and availability of systems and data. This seminar will provide you with an understanding of cybersecurity and its increasing regulatory focus, and how to embed and apply state-of-the-art security in your existing processes to deliver safe and secure products and solutions.

  • 6 CPD hours
  • Presented by Mr Ben Kokx
  • Next: 4-5 May 2023 Live online

Clinical Evaluation of Medical Devices: The Clinical Evaluation Report

Live online
Focused

Cover all the aspects of clinical evaluation in line with the European medical device regulations and applicable guidance documents

  • 12 CPD hours
  • Presented by Ms Janette Benaddi
  • Next: 8-9 May 2023 Live online

Quality Management Refresher

New for 2023

Live online
Focused

This seminar has been designed to provide a highly interactive session to refresh key personnel in the principles and practices of Quality Management and bring them up-to-date with the latest legal requirements. The seminar will review the key elements of the Pharmaceutical Quality System (PQS) and the roles and responsibilities of all staff involved in the PQS, including management. It will also provide a comprehensive overview of the essential principles and requirements of "The Orange Guide” and other relevant regulatory requirements.

  • 6 CPD hours
  • Presented by Rob Hughes
  • Next: 9-10 May 2023 Classroom

Medical Device Studies: Regulatory Requirements and Adverse Event Reporting

Classroom
Focused

An essential overview of medical device clinical evaluations, clinical investigations, post-market clinical follow-up requirements and adverse event and vigilance reporting.

  • 12 CPD hours
  • Presented by Ms Janette Benaddi
  • Next: 17-19 May 2023 Live online

An Introduction to the Medical Device Regulation

Live online
Focused

This seminar provides a detailed introduction to the European medical device legislation. It will explain the Regulation and which products are covered, the involvement of Notified Bodies, how to choose one and outline what a manufacturer must do.

  • 18 CPD hours
  • Presented by Ms Janette Benaddi
  • + 2 more
  • Next: 1-2 Jun 2023 Live online

Sterilization of Medical Devices

New for 2023

Live online
Focused

Sterile devices are free of viable microorganisms and sterilization is one of the key processes in the production of sterile medical devices. Regulations for medical devices include particular requirements for devices supplied or intended to be used in a sterile state. These regulatory requirements relate to general safety and performance aspects for the products, and the requirements for independent, third-party conformity assessment of the processes for achieving sterility. Evidence of successful sterilization is important and expected when demonstrating conformity with the regulations. This course provides a comprehensive overview of these regulatory requirements and how to comply, together with the science and standards that support them.

  • 12 CPD hours
  • Presented by Dr Eamonn Hoxey
  • Next: 6-9 Jun 2023 Live online

Advanced Regulatory Affairs for Medical Devices

Live online
Focused

Planning your regulatory strategy to comply with the Medical Device Regulation (MDR)

  • 12 CPD hours
  • Presented by Ms Janette Benaddi
  • and Ms Theresa Jeary
  • Next: 12-16 Jun 2023 Live online

The Medical Device School - From Concept to CE Marking

Live online
Intensive

This comprehensive course has been designed to map the processes from device concept to marketing and show how regulatory, quality, clinical and other aspects of device development are joined into a continuous process.

  • 30 CPD hours
  • Presented by Adrian Keene
  • + 7 more
  • Next: 13-14 Jun 2023 Classroom

Medical Device Regulations in the Middle East and North Africa

Classroom
Focused

This seminar will provide an essential overview of the key areas of requirements for product approvals for medical devices in the Middle East and North Africa. Covering Algeria, Bahrain, Egypt, Israel, Iran, Iraq, Jordan, Kuwait, Lebanon, Libya, Morocco, Oman, Palestine, Saudi Arabia, Sudan, Syria, Tunisia, UAE and Yemen

  • 12 CPD hours
  • Presented by Ms Ilona Putz
  • and Ms Heba Hashem
  • Next: 21-22 Jun 2023 Live online

FDA Approval Process for Medical Devices

Live online
Focused

This seminar will provide a solid foundation in the approval and clearance processes for medical devices in the United States including the underlying legal and regulatory requirements and the 'general controls' applicable to all devices.

  • 12 CPD hours
  • Presented by Dr Jonathan Hughes
  • Next: 22-23 Jun 2023 Classroom

Metered Dose Inhaler (MDI) Technology

Classroom
Focused

A comprehensive overview of MDIs including development, manufacture, regulation and market potential

  • 12 CPD hours
  • Presented by Mr David Howlett
  • Next: 29-30 Jun 2023 Classroom

New Regulations for Medical Devices and IVDs in Europe

Classroom
Focused

During a period of change and opportunity within the medical technology and diagnostics sectors, this seminar will help you prepare and operate successfully in Europe and the UK post Brexit.

  • 12 CPD hours
  • Presented by Dr David Jefferys
  • + 2 more
  • Next: 3-4 Jul 2023 Classroom

An Introduction to the Design and Development of Medical Devices

Classroom
Focused

A comprehensive introduction to the design and development of medical devices, including device constituent parts of combination products

  • 12 CPD hours
  • Presented by Mr David Howlett
  • Next: 3-6 Jul 2023 Classroom

Medical Device Software: Complying with the EU MDR, EU IVDR & FDA Regulations

Classroom
Focused

An introduction to medical device software regulations and requirements to include the latest EU and FDA guidance and risk management.

  • 24 CPD hours
  • Presented by Mr Koen Cobbaert
  • and Mrs Zuzanna Kwade
  • Next: 4-5 Jul 2023 Classroom

Medical Writing for Medical Devices

Classroom
Focused

How to produce quality regulatory documents including the clinical evaluation report (CER)

  • 12 CPD hours
  • Presented by Ms Barbara Grossman
  • and Ms Janette Benaddi
  • Next: 4-5 Jul 2023 Classroom

Medical Device Regulation in the Eurasion Union, Russia and the CIS

Classroom
Focused

A comprehensive overview of medical device regulatory affairs in Russia and the Eurasian Union. Key countries covered include Armenia, Azerbaijan, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, Turkmenistan and Ukraine.

  • 12 CPD hours
  • Presented by Mrs Anna Harrington-Morozova
  • Next: 5 Jul 2023 Classroom

Sustainable Design and Manufacture for Medical Devices

New for 2023

Classroom
Focused

Sustainability in medical technology, as in all industries, is increasingly no longer an option. It’s not a question of “if” – it’s a question of “how”. This seminar will give you an in depth understanding of what sustainability options exist, what the benefits are, what drives them, and how to choose which will work for your company. It will also provide practical advice on how to implement change.

  • 6 CPD hours
  • Presented by Cormac O'Prey
  • Next: 6-7 Jul 2023 Live online

Medical Device Single Audit Programme (MDSAP)

Live online
Focused

The Medical Device Single Audit Program (MDSAP) was developed by the International Medical Device Regulators Forum (IMDRF) to conduct regulatory audits of the quality management systems (QMS) used by manufacturers of medical devices. This course will prepare you to host a MDSAP audit within your organisation, and allow you to determine if your own internal QMS processes are consistent with requirements of the MDSAP for the jurisdictions where your products are marketed, or for those markets which you are planning to access.

  • 12 CPD hours
  • Presented by Dr Eamonn Hoxey
  • Next: 7 Jul 2023 Classroom

Cyber Security for Medical Devices

Classroom
Focused

The impact of Cyber Security incidents on society is high, and in critical infrastructures such as healthcare it impacts the ability for hospitals to provide care. Cybersecurity for medical devices is not just about safety, it should also protect the confidentiality, integrity and availability of systems and data. This seminar will provide you with an understanding of cybersecurity and its increasing regulatory focus, and how to embed and apply state-of-the-art security in your existing processes to deliver safe and secure products and solutions.

  • 6 CPD hours
  • Presented by Mr Ben Kokx
  • Next: 7 Jul 2023 Live online

EU Artificial Intelligence (AI) Act and its Impact on Medical Device Manufacturers

Live online
Focused

Many companies take part in the global ‘race to AI’ by continuously broadening the role of AI in their product portfolio. However, the rules of the game appear to be changing. The increased visibility of the technology’s risks has led to calls for regulators to look beyond the benefits, and also secure appropriate legislation to ensure AI that is ‘trustworthy’– legal, ethical, and robust. During this session, we will discuss the main players, trends, and challenges in the ‘race’ to AI regulation and how companies can move forward with an advantage.

  • 3 CPD hours
  • Presented by Mr Koen Cobbaert
  • Next: 12 Jul 2023 Classroom

Smart Packaging and Electronic Patient Information

New for 2023

Classroom
Focused

Increased use of SMART technologies has become ever more prevalent in the delivery of healthcare solutions as well as in the electronic delivery of Patient Information (e-PIL) and leaflets (e-leaflets). This course will provide an overview of the current technologies, the patient and societal benefits and some building blocks for the establishment and delivery of e-PIL and SMART strategic initiatives, providing insight as to where organisations may be most significantly impacted.

  • 6 CPD hours
  • Presented by Mr Christopher Waterhouse
  • Next: 12-13 Jul 2023 Classroom

Medical Device Studies: Clinical Evidence

Classroom
Focused

Gathering and using clinical evidence for CE marking and post-market compliance in line with the new MDR

  • 12 CPD hours
  • Presented by Ms Janette Benaddi
  • Next: 17-20 Jul 2023 Live online

Human Factors and Usability Engineering in the Development of Drug Delivery Products

Live online
Focused

Applying HF and usability to comply with the MDR. This two-day workshop has been designed specifically for product developers who want to incorporate human factors testing into their product development, or need to provide the regulators with specific usability data for their device.

  • 12 CPD hours
  • Presented by Mr Richard Featherstone
  • Next: 17 Jul 2023 Live online

UK Conformity Assessed (UKCA) Marking for Medical Devices

Live online
Focused

With the June 2023 UKCA mark deadline rapidly approaching, the challenges facing Medical Device companies, Regulators and Conformity Assessment Bodies are growing. The requirements for this new UKCA mark will impact technical documentation, labelling, logistics and regulatory compliance. The steps you need to take to prepare for the UKCA marking will depend on the current status of your business and your future market access requirements. This seminar will provide UK and global companies practical guidance on what you need to do to continue market access or gain market access with your medical device in the UK after June 2023.

  • 6 CPD hours
  • Presented by Ms Janette Benaddi
  • Next: 26-27 Jul 2023 Classroom

Introduction to the In-Vitro Diagnostic Regulation (IVDR)

Classroom
Focused

This two-day seminar will clarify the requirements applicable to in-vitro diagnostic devices under the IVD Regulation (EU) 2017/746. It will highlight the major changes to responsibility and product data expectations and will review the impact to industry.

  • 12 CPD hours
  • Presented by Nancy Consterdine
  • and Stuart Angell
  • Next: 27-28 Jul 2023 Live online

Pre-Filled Syringes: End-to-End Processing

Live online
Focused

Topics such as quality of syringe manufacture, quality of syringe components and why, quality of filling (volume check, reject reduction), quality of inspection and product release will be discussed in detail.

  • 6 CPD hours
  • Presented by Andreas Rothmund
  • and Dr. Dale Charlton
  • Next: 2-4 Aug 2023 Classroom

An Introduction to the Medical Device Regulation

Classroom
Focused

This seminar provides a detailed introduction to the European medical device legislation. It will explain the Regulation and which products are covered, the involvement of Notified Bodies, how to choose one and outline what a manufacturer must do.

  • 18 CPD hours
  • Presented by Ms Janette Benaddi
  • + 2 more
  • Next: 7-8 Aug 2023 Classroom

Clinical Evaluation of Medical Devices: The Clinical Evaluation Report

Classroom
Focused

Cover all the aspects of clinical evaluation in line with the European medical device regulations and applicable guidance documents

  • 12 CPD hours
  • Presented by Ms Janette Benaddi
  • Next: 13-14 Sep 2023 Live online

Metered Dose Inhaler (MDI) Technology

Live online
Focused

A comprehensive overview of MDIs including development, manufacture, regulation and market potential

  • 12 CPD hours
  • Presented by Mr David Howlett
  • Next: 18-19 Sep 2023 Classroom

Biological Evaluation of Medical Devices

Classroom
Focused

Key guidance on how to use the ISO 10993 series of standards and successfully apply a risk management approach to the biological evaluation of medical devices. *Includes:* Interactive workshops and discussion sessions

  • 12 CPD hours
  • Presented by Mr Philip Clay
  • and Rona Middlemiss
  • Next: 18-21 Sep 2023 Live online

Medical Device Studies: Regulatory Requirements and Adverse Event Reporting

Live online
Focused

An essential overview of medical device clinical evaluations, clinical investigations, post-market clinical follow-up requirements and adverse event and vigilance reporting.

  • 12 CPD hours
  • Presented by Ms Janette Benaddi
  • Next: 18-19 Sep 2023 Classroom

FDA Approval Process for Medical Devices

Classroom
Focused

This seminar will provide a solid foundation in the approval and clearance processes for medical devices in the United States including the underlying legal and regulatory requirements and the 'general controls' applicable to all devices.

  • 12 CPD hours
  • Presented by Dr Jonathan Hughes
  • Next: 28 Sep 2023 Classroom

Quality Management Refresher

New for 2023

Classroom
Focused

This seminar has been designed to provide a highly interactive session to refresh key personnel in the principles and practices of Quality Management and bring them up-to-date with the latest legal requirements. The seminar will review the key elements of the Pharmaceutical Quality System (PQS) and the roles and responsibilities of all staff involved in the PQS, including management. It will also provide a comprehensive overview of the essential principles and requirements of "The Orange Guide” and other relevant regulatory requirements.

  • 6 CPD hours
  • Presented by Rob Hughes
  • Next: 2-3 Oct 2023 Live online

New Regulations for Medical Devices and IVDs in Europe

Live online
Focused

During a period of change and opportunity within the medical technology and diagnostics sectors, this seminar will help you prepare and operate successfully in Europe and the UK post Brexit.

  • 12 CPD hours
  • Presented by Dr David Jefferys
  • + 2 more
  • Next: 2-5 Oct 2023 Live online

Medical Device Regulations in the Middle East and North Africa

Live online
Focused

This seminar will provide an essential overview of the key areas of requirements for product approvals for medical devices in the Middle East and North Africa. Covering Algeria, Bahrain, Egypt, Israel, Iran, Iraq, Jordan, Kuwait, Lebanon, Libya, Morocco, Oman, Palestine, Saudi Arabia, Sudan, Syria, Tunisia, UAE and Yemen

  • 12 CPD hours
  • Presented by Ms Ilona Putz
  • and Ms Heba Hashem
  • Next: 5-6 Oct 2023 Live online

An Introduction to the Design and Development of Medical Devices

Live online
Focused

A comprehensive introduction to the design and development of medical devices, including device constituent parts of combination products

  • 12 CPD hours
  • Presented by Mr David Howlett
  • Next: 6 Oct 2023 Live online

Sustainable Design and Manufacture for Medical Devices

New for 2023

Live online
Focused

Sustainability in medical technology, as in all industries, is increasingly no longer an option. It’s not a question of “if” – it’s a question of “how”. This seminar will give you an in depth understanding of what sustainability options exist, what the benefits are, what drives them, and how to choose which will work for your company. It will also provide practical advice on how to implement change.

  • 6 CPD hours
  • Presented by Cormac O'Prey
  • Next: 9-10 Oct 2023 Classroom

Advanced Regulatory Affairs for Medical Devices

Classroom
Focused

Planning your regulatory strategy to comply with the Medical Device Regulation (MDR)

  • 12 CPD hours
  • Presented by Ms Janette Benaddi
  • and Ms Theresa Jeary
  • Next: 18-19 Oct 2023 Live online

Cyber Security for Medical Devices

Live online
Focused

The impact of Cyber Security incidents on society is high, and in critical infrastructures such as healthcare it impacts the ability for hospitals to provide care. Cybersecurity for medical devices is not just about safety, it should also protect the confidentiality, integrity and availability of systems and data. This seminar will provide you with an understanding of cybersecurity and its increasing regulatory focus, and how to embed and apply state-of-the-art security in your existing processes to deliver safe and secure products and solutions.

  • 6 CPD hours
  • Presented by Mr Ben Kokx
  • Next: 19-20 Oct 2023 Live online

Sterilization of Medical Devices

New for 2023

Live online
Focused

Sterile devices are free of viable microorganisms and sterilization is one of the key processes in the production of sterile medical devices. Regulations for medical devices include particular requirements for devices supplied or intended to be used in a sterile state. These regulatory requirements relate to general safety and performance aspects for the products, and the requirements for independent, third-party conformity assessment of the processes for achieving sterility. Evidence of successful sterilization is important and expected when demonstrating conformity with the regulations. This course provides a comprehensive overview of these regulatory requirements and how to comply, together with the science and standards that support them.

  • 12 CPD hours
  • Presented by Dr Eamonn Hoxey
  • Next: 6-8 Nov 2023 Live online

An Introduction to the Medical Device Regulation

Live online
Focused

This seminar provides a detailed introduction to the European medical device legislation. It will explain the Regulation and which products are covered, the involvement of Notified Bodies, how to choose one and outline what a manufacturer must do.

  • 18 CPD hours
  • Presented by Ms Janette Benaddi
  • + 2 more
  • Next: 6-7 Nov 2023 Live online

Smart Packaging and Electronic Patient Information

New for 2023

Live online
Focused

Increased use of SMART technologies has become ever more prevalent in the delivery of healthcare solutions as well as in the electronic delivery of Patient Information (e-PIL) and leaflets (e-leaflets). This course will provide an overview of the current technologies, the patient and societal benefits and some building blocks for the establishment and delivery of e-PIL and SMART strategic initiatives, providing insight as to where organisations may be most significantly impacted.

  • 6 CPD hours
  • Presented by Mr Christopher Waterhouse
  • Next: 7-10 Nov 2023 Live online

Introduction to the In-Vitro Diagnostic Regulation (IVDR)

Live online
Focused

This two-day seminar will clarify the requirements applicable to in-vitro diagnostic devices under the IVD Regulation (EU) 2017/746. It will highlight the major changes to responsibility and product data expectations and will review the impact to industry.

  • 12 CPD hours
  • Presented by Nancy Consterdine
  • and Stuart Angell
  • Next: 8 Nov 2023 Live online

Pre-Filled Syringes: End-to-End Processing

Live online
Focused

Topics such as quality of syringe manufacture, quality of syringe components and why, quality of filling (volume check, reject reduction), quality of inspection and product release will be discussed in detail.

  • 6 CPD hours
  • Presented by Andreas Rothmund
  • and Dr. Dale Charlton
  • Next: 9 Nov 2023 Live online

EU Artificial Intelligence (AI) Act and its Impact on Medical Device Manufacturers

Live online
Focused

Many companies take part in the global ‘race to AI’ by continuously broadening the role of AI in their product portfolio. However, the rules of the game appear to be changing. The increased visibility of the technology’s risks has led to calls for regulators to look beyond the benefits, and also secure appropriate legislation to ensure AI that is ‘trustworthy’– legal, ethical, and robust. During this session, we will discuss the main players, trends, and challenges in the ‘race’ to AI regulation and how companies can move forward with an advantage.

  • 3 CPD hours
  • Presented by Mr Koen Cobbaert
  • Next: 13-14 Nov 2023 Live online

Medical Device Studies: Clinical Evidence

Live online
Focused

Gathering and using clinical evidence for CE marking and post-market compliance in line with the new MDR

  • 12 CPD hours
  • Presented by Ms Janette Benaddi
  • Next: 21 Nov 2023 Live online

UK Conformity Assessed (UKCA) Marking for Medical Devices

Live online
Focused

With the June 2023 UKCA mark deadline rapidly approaching, the challenges facing Medical Device companies, Regulators and Conformity Assessment Bodies are growing. The requirements for this new UKCA mark will impact technical documentation, labelling, logistics and regulatory compliance. The steps you need to take to prepare for the UKCA marking will depend on the current status of your business and your future market access requirements. This seminar will provide UK and global companies practical guidance on what you need to do to continue market access or gain market access with your medical device in the UK after June 2023.

  • 6 CPD hours
  • Presented by Ms Janette Benaddi
  • Next: 23-24 Nov 2023 Live online

Medical Writing for Medical Devices

Live online
Focused

How to produce quality regulatory documents including the clinical evaluation report (CER)

  • 12 CPD hours
  • Presented by Ms Barbara Grossman
  • and Ms Janette Benaddi
  • Next: 28-29 Nov 2023 Live online

Human Factors and Usability Engineering in the Development of Drug Delivery Products

Live online
Focused

Applying HF and usability to comply with the MDR. This two-day workshop has been designed specifically for product developers who want to incorporate human factors testing into their product development, or need to provide the regulators with specific usability data for their device.

  • 12 CPD hours
  • Presented by Mr Richard Featherstone
  • Next: 29-30 Nov 2023 Live online

Clinical Evaluation of Medical Devices: The Clinical Evaluation Report

Live online
Focused

Cover all the aspects of clinical evaluation in line with the European medical device regulations and applicable guidance documents

  • 12 CPD hours
  • Presented by Ms Janette Benaddi
  • Next: 30 Nov-1 Dec 2023 Classroom

Medical Device Single Audit Programme (MDSAP)

Classroom
Focused

The Medical Device Single Audit Program (MDSAP) was developed by the International Medical Device Regulators Forum (IMDRF) to conduct regulatory audits of the quality management systems (QMS) used by manufacturers of medical devices. This course will prepare you to host a MDSAP audit within your organisation, and allow you to determine if your own internal QMS processes are consistent with requirements of the MDSAP for the jurisdictions where your products are marketed, or for those markets which you are planning to access.

  • 12 CPD hours
  • Presented by Dr Eamonn Hoxey
  • Next: 4-5 Dec 2023 Live online

FDA Approval Process for Medical Devices

Live online
Focused

This seminar will provide a solid foundation in the approval and clearance processes for medical devices in the United States including the underlying legal and regulatory requirements and the 'general controls' applicable to all devices.

  • 12 CPD hours
  • Presented by Dr Jonathan Hughes
  • Next: 4-8 Dec 2023 Live online

The Medical Device School - From Concept to CE Marking

Live online
Intensive

This comprehensive course has been designed to map the processes from device concept to marketing and show how regulatory, quality, clinical and other aspects of device development are joined into a continuous process.

  • 30 CPD hours
  • Presented by Adrian Keene
  • + 7 more
  • Next: 11-14 Dec 2023 Live online

Medical Device Software: Complying with the EU MDR, EU IVDR & FDA Regulations

Live online
Focused

An introduction to medical device software regulations and requirements to include the latest EU and FDA guidance and risk management.

  • 24 CPD hours
  • Presented by Mr Koen Cobbaert
  • and Mrs Zuzanna Kwade
  • Next: 11-12 Dec 2023 Live online

Medical Device Regulation in the Eurasion Union, Russia and the CIS

Live online
Focused

A comprehensive overview of medical device regulatory affairs in Russia and the Eurasian Union. Key countries covered include Armenia, Azerbaijan, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, Turkmenistan and Ukraine.

  • 12 CPD hours
  • Presented by Mrs Anna Harrington-Morozova