Scheduled In-house

Medical Devices Training Courses

With our extensive faculty of expert speakers with experience in the field of medical devices, we deliver a variety of medical device training courses that are relevant, will keep you abreast of regulatory changes, are highly interactive and offer a great opportunity for you to network with others working in the medical device industry.

The constant development of new medical devices, alongside changes and updates to regulations, create an ever-changing landscape in the medical device field  Whether you are looking to develop your understanding of drug/delivery combination products, keep up-to-date with the latest EU and FDA regulatory requirements, learn about clinical studies, or hear the latest on the use of medical device software and emerging technologies.  IPI Academy offers a wide selection of medical device training courses for you to extend your knowledge, hear the latest regulatory updates and focus on particular areas of Medical Devices.

View calendar Need help? 

  • Next: 4 Jun 2024 Live online
  • Also: 5 Dec 2024 Live online

Unique Device Identification (UDI) and Labelling for Medical Device Manufacturers

New for 2024

Live online

The information supplied with medical devices, both on their labels and in any accompanying Instructions for Use form part of the device itself, and are critical to the safety and performance of the device and to compliance with regulatory requirements. This course provides an introduction to the regulatory requirements as they relate to the labelling of medical devices and how manufacturers may demonstrate compliance.

  • 3 CPD hours High impact
  • Presented by Annette Callaghan
  • Next: 4-7 Jun 2024 Live online
  • Also: 7-8 Oct 2024 Live online

Advanced Regulatory Affairs for Medical Devices

Live online

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

  • 12 CPD hours Focused
  • Presented by Janette Benaddi
  • and Theresa Jeary
  • Next: 16-17 Sep 2024 Classroom

Biological Evaluation of Medical Devices

Classroom

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 Focused
  • Presented by Philip Clay
  • and Rona Middlemiss
  • Next: 9-10 May 2024 Live online
  • Also: 5-6 Aug 2024 Classroom
  • Also: 27-28 Nov 2024 Live online

Clinical Evaluation of Medical Devices: The Clinical Evaluation Report

Live online, Classroom

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

  • 12 CPD hours Focused
  • Presented by Janette Benaddi
  • Next: 20-21 Jun 2024 Live online
  • Also: 14-15 Oct 2024 Live online

Cosmetovigilance

Updated for 2024

Live online

This course will provide a comprehensive overview of cosmetogivilance in Europe, the USA and the Rest of the World (ROW). It will provide key guidance for manufacturers and distributors on how to comply with the regulatory requirements, and will be valuable for pharmaceutical and medical device companies looking to access the cosmetic market.

  • 12 CPD hours Focused
  • Presented by Dr Graeme Ladds
  • Next: 2-3 May 2024 Live online
  • Also: 4-5 Jul 2024 Classroom
  • Also: 15-16 Oct 2024 Live online

Cyber Security for Medical Devices

Live online, Classroom

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.

  • 12 CPD hours Focused
  • Presented by Ben Kokx
  • Next: 4 Jun 2024 Live online
  • Also: 8 Oct 2024 Live online

Delivery of Biologics to the Nasal Cavity

Live online

The nasal cavity is an established pathway to treat local diseases as well as systemic conditions using small molecules. As the pharmaceutical industry shifts towards targeted biologics, the nasal cavity is also an attractive target for delivery of peptides, monoclonal antibodies, nucleic acids and stem cells. This is an ideal opportunity to hear from experts in the field of nasal drug delivery who will address topics such as: challenges associated with formulation, barriers to cell penetration and absorption, the pros and cons for liquid versus powder formulations, and strategies for maintaining stability and prolonging retention in the nasal cavity.

  • 3 CPD hours Focused
  • Presented by Dr Irene Rossi
  • + 3 more
  • Next: 8-9 Jul 2024 Live online
  • Also: 8 Nov 2024 Live online

An Essential Overview of the Medical Device Industry

Live online

This one-day workshop aims to give all the key information necessary to understand the regulation of medical devices and diagnostics and to appreciate the key differences from pharmaceutical regulation.

  • 6 CPD hours Focused
  • Presented by Dr David Jefferys
  • and Theresa Jeary
  • Next: 4-7 Mar 2024 Live online
  • Also: 19-20 Jun 2024 Live online
  • Also: 10-11 Sep 2024 Classroom
  • Also: 2-3 Dec 2024 Live online

FDA Approval Process for Medical Devices

Live online, Classroom

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 Focused
  • Presented by Dr Jonathan Hughes
  • Next: 5-6 Jun 2024 Classroom
  • Also: 17-20 Sep 2024 Live online
  • Also: 5-6 Dec 2024 Live online

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

Live online, Classroom

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 Focused
  • Presented by Richard Featherstone
  • Next: 1 May 2024 Live online
  • Also: 11 Nov 2024 Live online

An Introduction to Ethylene Oxide (EO) Sterilization for Medical Devices

New for 2024

Live online

Sterile devices are free of viable microorganisms and EO sterilization is one of the key processes in the production of sterile medical devices. This course provides an introduction to the regulatory requirements as they relate to EO sterilisation and how manufacturers may demonstrate compliance.

  • 3 CPD hours
  • Presented by Annette Callaghan
  • Next: 24 Apr 2024 Live online
  • Also: 10 Jul 2024 Classroom
  • Also: 23 Oct 2024 Live online

An Introduction to Human Factors for Pharmaceutical and Medical Device Professionals

New for 2024

Live online, Classroom

This course will cover the key regulations used globally in human factors and usability engineering, the specific standards and guidances that detail processes, methods, and the tools commonly used in medical device development that focus on the user, as well as the interaction with risk management and future business success.

  • Presented by Greg Thay
  • Next: 21 May 2024 Live online
  • Also: 18 Nov 2024 Live online

An Introduction to ISO 11607 - Packaging for Terminally Sterilized Medical Devices

New for 2024

Live online

Sterile devices are free of viable microorganisms and the sterile barrier system is the key to maintaining this sterility until the medical device is ready to be used on a patient. This course provides an introduction to the regulatory requirements as they relate to typical sterile barrier systems used for single-use and reusable medical devices, and how manufacturers may demonstrate compliance.

  • 3 CPD hours
  • Presented by Annette Callaghan
  • Next: 4 Jul 2024 Classroom
  • Also: 20 Nov 2024 Live online

An Introduction to ISO 13485: 2016 - Quality Management System (QMS) for Medical Devices

New for 2024

Live online, Classroom

This course has been specifically designed to provide an essential introduction to ISO 13485 and the QMS and provides a comprehensive and valuable overview of the requirements and responsibilities involved. Where ever you and your company sit within the medical device arena this is an excellent opportunity to become appraised of the requirements.

  • 6 CPD hours Focused
  • Presented by Stuart Angell
  • Next: 22-23 Apr 2024 Live online
  • Also: 24-25 Jul 2024 Live online
  • Also: 10-11 Dec 2024 Live online

An Introduction to the Design and Development of Medical Devices

Live online

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

  • 12 CPD hours Focused
  • Presented by David Howlett
  • Next: 24-25 Jul 2024 Live online
  • Also: 5-8 Nov 2024 Live online

Introduction to the In-Vitro Diagnostic Regulation (IVDR)

Live online

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 Focused
  • Presented by Nancy Consterdine
  • and Stuart Angell
  • Next: 15-17 May 2024 Live online
  • Also: 31 Jul-2 Aug 2024 Classroom
  • Also: 4-6 Nov 2024 Live online

An Introduction to the Medical Device Regulation

Live online, Classroom

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 Focused
  • Presented by Janette Benaddi
  • + 2 more
  • Next: 1 May 2024 Live online
  • Also: 5 Nov 2024 Live online

Managing Competence within the Medical Device Industry

New for 2024

Live online

This webinar has been designed to help you understand the ‘big picture’ of competence management, from selection of the right competencies for success to the maintenance of collective organisational knowledge.

  • 1.5 CPD hours
  • Presented by Anne Jury
  • Next: 6 Mar 2024 Live online
  • Also: 26 Jul 2024 Live online
  • Also: 7 Nov 2024 Live online

Masterclass: Artificial Intelligence-based Medical Devices

Live online

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 and to ensure data is portable and qualitative. 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.

  • 6 CPD hours Focused
  • Presented by Koen Cobbaert
  • Next: 16-19 Apr 2024 Live online
  • Also: 2-3 Jul 2024 Live online
  • Also: 9-10 Dec 2024 Live online

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

Live online

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 Focused
  • Presented by Anna Harrington-Morozova
  • Next: 11-12 Jun 2024 Live online
  • Also: 7-8 Oct 2024 Live online

Medical Device Regulations in the Middle East and North Africa

Live online

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 Focused
  • Presented by Heba Hashem
  • and Ilona Putz
  • Next: 10-14 Jun 2024 Classroom
  • Also: 2-6 Dec 2024 Live online

The Medical Device School - From Concept to CE Marking

Summer school

Live online, Classroom

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 Intensive
  • Presented by Adrian Keene
  • + 7 more
  • Next: 25-26 Mar 2024 Live online
  • Also: 4-5 Jul 2024 Live online
  • Also: 28-29 Nov 2024 Live online

Medical Device Single Audit Programme (MDSAP)

Live online

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 Focused
  • Presented by Stuart Angell
  • Next: 22-25 Apr 2024 Classroom
  • Also: 22-25 Jul 2024 Live online
  • Also: 9-12 Dec 2024 Live online

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

Live online, Classroom

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

  • 24 CPD hours Focused
  • Presented by Koen Cobbaert
  • and Zuzanna Kwade
  • Next: 10-11 Jul 2024 Live online
  • Also: 11-12 Nov 2024 Live online

Medical Device Studies: Clinical Evidence

Live online

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

  • 12 CPD hours Focused
  • Presented by Janette Benaddi
  • Next: 21-22 May 2024 Live online
  • Also: 16-19 Sep 2024 Live online

Medical Device Studies: Regulatory Requirements and Adverse Event Reporting

Live online

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 Focused
  • Presented by Janette Benaddi
  • Next: 13-14 Mar 2024 Live online
  • Also: 1-2 Jul 2024 Live online
  • Also: 21-22 Nov 2024 Live online

Medical Writing for Medical Devices

Live online

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

  • 12 CPD hours Focused
  • Presented by Barbara Grossman
  • and Janette Benaddi
  • Next: 20-21 Jun 2024 Live online
  • Also: 9-10 Oct 2024 Live online

Metered Dose Inhaler (MDI) Technology

Live online

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

  • 12 CPD hours Focused
  • Presented by David Howlett
  • Next: 19 Jun 2024 Live online
  • Also: 12 Dec 2024 Live online

Non-Conformance and Corrective Action for Medical Device Manufacturers

New for 2024

Live online

The identification of non-conformances and ensuring that they are dealt with in a timely and appropriate manner is a key part of any medical device Quality Management System (QMS). This course provides an introduction to the regulatory requirements as they relate to the identification and handling of non-conformances and how manufacturers may demonstrate compliance.

  • 3 CPD hours Masterclass
  • Presented by Annette Callaghan
  • Next: 6 Jun 2024 Live online
  • Also: 10 Oct 2024 Live online

Post-Market Surveillance - Practical Application for Medical Devices and IVDs

New for 2024

Live online

Understanding the regulatory requirements for successful post-market surveillance of medical devices and IVDs is increasingly important and practical application of the regulations is key to a successful PMS system. This course will provide a clear understanding of the intention of the requirements, and discuss the responsibilities of the manufacturer, notified bodies and competent authorities.

  • 6 CPD hours
  • Presented by Anne Jury
  • and Karen Pearson
  • Next: 21-22 Mar 2024 Live online
  • Also: 25-26 Jul 2024 Live online
  • Also: 6-7 Nov 2024 Live online

Pre-Filled Syringes: End-to-End Processing

Live online

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 Focused
  • Presented by Andreas Rothmund
  • + 3 more
  • Next: 5-6 Jun 2024 Classroom
  • Also: 15-16 Oct 2024 Live online

Process Validation for Medical Devices

New for 2024

Live online, Classroom

This course focuses on the Regulatory and Quality Management System links to Process Validation for medical devices, and reviews the Installation Qualification, Operation Qualification and Performance Qualification Processes and how these fit with regulatory needs and technical documentation.

  • 12 CPD hours
  • Next: 30 Apr 2024 Live online
  • Also: 22 Oct 2024 Live online

A Regulatory Update on the Medical Device and In-Vitro Diagnostic Regulations in the EU and UK

Updated for 2024

Live online

This course will provide an excellent opportunity to hear the latest developments from regulatory experts, and enable participants to discuss the implications of the regulations on working practices and the potential impact on future regulatory strategies.

  • 12 CPD hours Focused
  • Presented by Sue Spencer
  • + 4 more
  • Next: 21 May 2024 Classroom
  • Also: 24 Sep 2024 Live online

The Role of the Person Responsible for Regulatory Compliance (PRRC) Under the MDR and IVDR

Live online, Classroom

This one day course will cover the role of the Person Responsible for Regulatory Compliance (PRRC) introduced by the implementation of the Medical Device Regulation 2017/745 and the In-Vitro Diagnostic Device Regulation 2017/746. The course will review Article 15 from the regulation in detail to enable understanding of the intent of each requirement. It will also present the UK Medical Device Regulation requirements and discuss the proposed Qualified Person role with current information.

  • 6 CPD hours
  • Presented by Stuart Angell
  • Next: 14 Mar 2024 Live online
  • Also: 10 Jul 2024 Live online
  • Also: 4-5 Nov 2024 Live online

Smart Packaging and Electronic Patient Information

New for 2024

Live online

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 Focused
  • Presented by Mr Graham Howieson
  • Next: 6-7 Jun 2024 Live online
  • Also: 17-18 Oct 2024 Live online

Sterilization of Medical Devices

Live online

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 Focused
  • Presented by Annette Callaghan
  • Next: 25 Apr 2024 Classroom
  • Also: 4 Jul 2024 Live online
  • Also: 4 Oct 2024 Classroom

Sustainable Design and Manufacture for Medical Devices

Live online, Classroom

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 Focused
  • Presented by Cormac O'Prey
  • Next: 15 Jul 2024 Live online
  • Also: 19 Nov 2024 Live online

UK Conformity Assessed (UKCA) Marking for Medical Devices

Live online

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 Focused
  • Presented by Janette Benaddi
  • Recorded webcast

Human Factors - The Increasing Importance of Instructions for Use

Free

Recorded webcast

This free webinar will focus on the often overlooked but increasingly important area of Instructions for Use for medical products. From the perspective of human factors and usability engineering, Instructions for Use significantly impact the performance of the user to use medical devices safely and effectively and often are only used when the user has a problem. The webinar will look at why we need Instructions for Use to be usable, not only for safety but for regulatory approval and how you achieve that. It will address what predictions can be made from existing data and discuss what the future of Instructions for Use could be. This is an excellent opportunity to learn more about this important element of your regulatory submission.

  • 1.5 CPD hours High impact
  • Presented by Greg Thay
  • Webcast & report

Sustainable Design and Manufacture for Medical Devices

Free

Webcast & report

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