- Next: 27-28 Sep 2022 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: 4-5 Jul 2022 Live online
- Also: 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: 18-20 May 2022 Live online
- Also: 1-3 Aug 2022 Classroom
- Also: 8-10 Nov 2022 Live online
An Introduction to the Medical Device Regulation
Live online, 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: 1-2 Aug 2022 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
- Next: 8-9 Aug 2022 Classroom
- Also: 28-29 Nov 2022 Live online
Clinical Evaluation of Medical Devices: The Clinical Evaluation Report
Live online, 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: 19 Jul 2022 Live online
- Also: 11 Oct 2022 Live online
- Also: 20 Jan 2023 Classroom
Cyber Security for Medical Devices
Live online, 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: 29-30 Sep 2022 Live online
- Also: 14-15 Dec 2022 Classroom
Drug/Device and Device/Drug Combinations in the EU and USA
Live online, Classroom
Focused
Practical guidance on borderline Issues and combination products
- 12 CPD hours
-
Presented by Dr David Jefferys
-
+ 3 more
- Next: 8 Nov 2022 Live online
- Also: 1 Mar 2023 Live online
- Also: 13 Jul 2023 Live online
- Also: 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: 22-23 Jun 2022 Live online
- Also: 12-13 Sep 2022 Live online
- Also: 5-6 Dec 2022 Classroom
FDA Approval Process for Medical Devices
Live online, 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: 14-15 Sep 2022 Live online
- Also: 7-8 Dec 2022 Classroom
Human Factors and Usability Engineering in the Development of Drug Delivery Products
Live online, 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: 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: 5-6 Jul 2022 Live online
- Also: 12-13 Oct 2022 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: 15-16 Jun 2022 Live online
- Also: 20-21 Sep 2022 Classroom
- Also: 7-8 Dec 2022 Live online
Medical Device Regulations in the Middle East and North Africa
Live online, 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 Heba Hashem
-
and Ms Ilona Putz
- Next: 7-8 Jul 2022 Live online
- Also: 1-2 Dec 2022 Classroom
- Also: 23-24 Mar 2023 Live online
Medical Device Single Audit Programme (MDSAP)
Live online, 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: 4-7 Jul 2022 Classroom
- Also: 4-7 Oct 2022 Live online
Medical Device Software: Complying with the EU MDR, EU IVDR & FDA Regulations
Live online, 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: 15-16 Aug 2022 Classroom
- Also: 14-15 Nov 2022 Live online
Medical Device Studies: Clinical Evidence
Live online, 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: 19-20 Sep 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: 5-6 Jul 2022 Live online
- Also: 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: 13-14 Sep 2022 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 Jun-1 Jul 2022 Live online
- Also: 13-14 Oct 2022 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: 21 Sep 2022 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: 29 Sep 2022 Classroom
- Also: 26 Jan 2023 Live online
Quality Management Refresher
Live online, 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: 13 Jul 2022 Classroom
- Also: 2 Nov 2022 Classroom
Smart Packaging and Electronic Patient Information
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: 20-21 Oct 2022 Live online
- Also: 2-3 Feb 2023 Classroom
- Also: 1-2 Jun 2023 Live online
Sterilization of Medical Devices
Live online, 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
- 19 Jan 2022
Sustainable Design and Manufacture for Medical Devices
Recorded webcast
High impact
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 free webinar will give you a high level of understanding of what sustainability options exist, what the benefits are and what drives them.
-
Presented by Cormac O'Prey
- Next: 6 Jul 2022 Live online
- Also: 6 Oct 2022 Live online
- Also: 24 Jan 2023 Classroom
Sustainable Design and Manufacture for Medical Devices
Live online, 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: 22-23 Nov 2022 Live online
Technical Documentation to Comply with the MDR and IVDR
Live online
Focused
This seminar will provide essential guidance on the content of the technical documentation file, the changes required and the practicalities of compiling and maintaining the technical file to comply with the MDR and IVDR.
- 12 CPD hours
-
Presented by Paul Sim
-
and Mr Will Burton
- Next: 13-17 Jun 2022 Live online
- Also: 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 Mr David Howlett
-
+ 7 more
- Next: 13 Jul 2022 Live online
- Also: 3 Nov 2022 Live online
- Also: 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