Training courses & Webinars:
Medical Devices

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.  Management Forum 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.

 

Please note: full product details will be shown on our training portal IPI Academy where you can find out more and book

A Regulatory Update on the Medical Device and In-Vitro Diagnostic Regulations in the EU (European Union) and UK Training Course

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

30 Apr 2025 - Online webinar
Also on: 21 Oct 2025

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.

Presented by Theresa Jeary (bio)
and 4 more leading experts

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Advanced Regulatory Affairs for Medical Devices Training Course

Advanced Regulatory Affairs for Medical Devices

13-14 Feb 2025 - Online webinar
Also on: 3 Jun 2025

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

Presented by Janette Benaddi (bio)
Theresa Jeary (bio)

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An Essential Overview of the Medical Device Industry Training Course

An Essential Overview of the Medical Device Industry

14 Mar 2025 - Online webinar
Also on: 3 Jul 2025

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.

Presented by Theresa Jeary (bio)
David Jefferys (bio)

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

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

11 Nov 2024 - Online webinar
Also on: 1 May 2025

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.

Presented by Annette Callaghan (bio)

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An Introduction to Human Factors for Pharmaceutical and Medical Device Professionals Training Course

An Introduction to Human Factors for Pharmaceutical and Medical Device Professionals

17 Mar 2025 - Online webinar
Also on: 9 Jul 2025

This course will cover the key regulations used globally in human factors and usability engineering: the specific standards and guidances, methods, and the tools commonly used in medical device development.

Presented by Greg Thay (bio)

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

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

22 May 2025 - Online webinar
Also on: 17 Nov 2025

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.

Presented by Annette Callaghan (bio)

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

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

13 Mar 2025 - Online webinar
Also on: 3 Jul 2025

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.

Presented by Linda Garrod (bio)

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An introduction to Risk Management ISO 14971:2019 Training Course

An introduction to Risk Management ISO 14971:2019

11 Mar 2025 - Online webinar
Also on: 11 Jul 2025

Dive into the core principles of risk management using ISO14971:2019. Learn to assess, analyse, and mitigate risks effectively, ensuring compliance with international standards and enhancing decision-making in various industries.

Presented by Linda Garrod (bio)

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An Introduction to the Design and Development of Medical Devices Training Course

An Introduction to the Design and Development of Medical Devices

10-11 Dec 2024 - Online webinar
Also on: 8 Apr 2025

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

Presented by David Howlett (bio)

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An Introduction to the Medical Device Regulation Training Course

An Introduction to the Medical Device Regulation

25-27 Mar 2025 - Online webinar
Also on: 16 Jul 2025

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.

Presented by Janette Benaddi (bio)
Will Burton (bio)
Theresa Jeary (bio)

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Best Practices for Supplier Qualification in Life Science Training Course

Best Practices for Supplier Qualification in Life Science

27-28 Mar 2025 - Online webinar
Also on: 16 Jul 2025

Explore the intricacies of Life Science Supplier Qualification through our comprehensive course. Gain expert insights into regulatory compliance, supply chain optimization, and strategic sourcing. Elevate your proficiency in maintaining product integrity with proven industry best practices.

Presented by Mustafa Edik (bio)

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Biological Evaluation of Medical Devices Training Course

Biological Evaluation of Medical Devices

15-16 Jan 2025 - Online webinar
Also on: 15 May 2025

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

Presented by Annette Callaghan (bio)

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Classification of Software as a Medical Device (SaMD) and Medical Device Software (MDSW) Training Course

Classification of Software as a Medical Device (SaMD) and Medical Device Software (MDSW)

28 Feb 2025 - Online webinar
Also on: 9 Jul 2025

Master the complexities of software classification under the Medical Device Regulations (MDR), ensuring compliance and clarity with expert insights into MDCG guidelines, practical case studies, and regulatory frameworks.

Presented by Koen Cobbaert (bio)

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Clinical Evaluation of Medical Device Software and Software as a Medical Device Training Course

Clinical Evaluation of Medical Device Software and Software as a Medical Device

22 Jan 2025 - Online webinar
Also on: 13 May 2025

This one-day course will provide a clear understanding of the clinical evaluation requirements and their practical application for software products, including AI/ML-based devices.

Presented by Zuzanna Kwade (bio)

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Clinical Evaluation of Medical Devices: The Clinical Evaluation Report Training Course

Clinical Evaluation of Medical Devices: The Clinical Evaluation Report

31 Mar-3 Apr 2025 - Online webinar
Also on: 21 Jul 2025

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

Presented by Janette Benaddi (bio)

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Cosmetovigilance Training Course

Cosmetovigilance

3-4 Feb 2025 - Online webinar
Also on: 19 Jun 2025

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.

Presented by Graeme Ladds (bio)

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Cyber Security for Medical Devices Training Course

Cyber Security for Medical Devices

28-29 Jan 2025 - Online webinar
Also on: 8 May 2025

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.

Presented by Ben Kokx (bio)

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Data Innovation for AI-enabled Medical Devices Training Course

Data Innovation for AI-enabled Medical Devices

28 Feb 2025 - Online webinar
Also on: 9 Jul 2025

This course provides an in-depth understanding of data governance for AI-enabled medical devices, focusing on European regulations like the AI Act and GDPR, ensuring compliance while fostering innovation in high-risk AI systems.

Presented by Koen Cobbaert (bio)

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Deep Dive into the IVDR (In-Vitro Diagnostic Regulation) Annex XIII Training Course

Deep Dive into the IVDR Annex XIII

5 Mar 2025 - Online webinar
Also on: 10 Jul 2025

Explore IVDR Annex XIII in-depth, covering Performance Evaluation, Performance Studies, and Post-market Performance. Learn what information is required, where to put it, and when, with a detailed review of nine essential documents.

Presented by Jane Leadsham (bio)

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Developing and Managing Software as a Medical Device (SaMD) and Medical Device Software (MDSW) Training Course

Developing and Managing Software as a Medical Device (SaMD) and Medical Device Software (MDSW)

3 Mar 2025 - Online webinar
Also on: 10 Jul 2025

Gain essential knowledge in developing and managing Software as a Medical Device (SaMD) and Medical Device Software (MDSW), focusing on regulatory compliance, risk management, and lifecycle management to ensure safety and effectiveness.

Presented by Koen Cobbaert (bio)

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FDA (Food and Drug Administration) Approval Process for Medical Devices Training Course

FDA Approval Process for Medical Devices

2-3 Dec 2024 - Online webinar
Also on: 31 Mar 2025

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.

Presented by Jonathan Hughes (bio)

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

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

5-6 Dec 2024 - Online webinar
Also on: 15 Jan 2025

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.

Presented by Richard Featherstone (bio)

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Introduction to the In-Vitro Diagnostic Regulation (IVDR) Training Course

Introduction to the In-Vitro Diagnostic Regulation (IVDR)

5-6 Feb 2025 - Online webinar
Also on: 16 Jul 2025

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.

Presented by Stuart Angell (bio)

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Introduction to the New Performance Evaluation Requirements Mandated Under the IVDR (2017/746) Training Course

Introduction to the New Performance Evaluation Requirements Mandated Under the IVDR (2017/746)

4 Mar 2025 - Online webinar
Also on: 9 Jul 2025

Understand the essentials of performance evaluation under the In Vitro Diagnostic Regulation (2017/746) in this comprehensive seminar. Essential for regulatory compliance and business success.

Presented by Jane Leadsham (bio)

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Managing Competence within the Medical Device Industry Training Course

Managing Competence within the Medical Device Industry

26 Mar 2025 - Online webinar
Also on: 11 Jul 2025

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.

Presented by Anne Jury (bio)

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Market Authorisation of Software as a Medical Device (SaMD) and Medical Device Software (MDSW) Training Course

Market Authorisation of Software as a Medical Device (SaMD) and Medical Device Software (MDSW)

26-27 Feb 2025 - Online webinar
Also on: 7 Jul 2025

Learn the critical regulatory requirments and best practices for obtaining market authorisation or Software as a Medical Device (SaMD) and Medical Device Software (MDSW) in global markets.

Presented by Koen Cobbaert (bio)

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Masterclass: Market Authorisation of AI-enabled Medical Devices Training Course

Masterclass: Market Authorisation of AI-enabled Medical Devices

4 Apr 2025 - Online webinar
Also on: 11 Jul 2025

This course provides essential guidance on navigating regulatory requirements and securing market authorization for AI-based medical devices, covering key regulations, compliance strategies, and best practices for global market access.

Presented by Koen Cobbaert (bio)

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

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

9-10 Dec 2024 - Online webinar
Also on: 3 Apr 2025

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.

Presented by Anna Harrington-Morozova (bio)

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Medical Device Regulations in the Middle East and North Africa Training Course

Medical Device Regulations in the Middle East and North Africa

10-11 Mar 2025 - Online webinar
Also on: 23 Jul 2025

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.

Presented by Heba Hashem (bio)
Ilona Putz (bio)

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Medical Device Single Audit Programme (MDSAP) Training Course

Medical Device Single Audit Programme (MDSAP)

24-25 Mar 2025 - Online webinar
Also on: 10 Jul 2025

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.

Presented by Stuart Angell (bio)

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

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

18-21 Nov 2024 - Online webinar

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

Presented by Koen Cobbaert (bio)
Zuzanna Kwade (bio)

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Medical Device Studies: Clinical Evidence Training Course

Medical Device Studies: Clinical Evidence

17-18 Mar 2025 - Online webinar
Also on: 9 Jul 2025

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

Presented by Janette Benaddi (bio)

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Medical Device Studies: Regulatory Requirements and Adverse Event Reporting Training Course

Medical Device Studies: Regulatory Requirements and Adverse Event Reporting

15-16 Jan 2025 - Online webinar
Also on: 7 May 2025

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

Presented by Janette Benaddi (bio)

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Medical Writing for Medical Devices Training Course

Medical Writing for Medical Devices

25-26 Nov 2024 - Online webinar
Also on: 1 Jul 2025

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

Presented by Janette Benaddi (bio)
Barbara Grossman (bio)

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Metered Dose Inhaler (MDI) Technology Training Course

Metered Dose Inhaler (MDI) Technology

24-27 Feb 2025 - Online webinar
Also on: 19 Jun 2025

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

Presented by David Howlett (bio)

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Navigating EU (European Union) and FDA (Food and Drug Administration) Regulations for Drug/Device and Device/Drug Combination Products Training Course

Navigating EU and FDA Regulations for Drug/Device and Device/Drug Combination Products

21-22 Jan 2025 - Online webinar
Also on: 19 May 2025

Gain practical guidance on the complex regulatory landscapes of EU and FDA for drug/device & device/drug combination products in this comprehensive course.

Presented by Tina Amini (bio)
and 3 more leading experts

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Navigating Regulatory Compliance Whilst Developing and Distributing PCR-Based IVD Tests Training Course

Navigating Regulatory Compliance Whilst Developing and Distributing PCR-Based IVD Tests

6 Mar 2025 - Online webinar
Also on: 26 Jun 2025

In this three-hour course, learn from an expert about developing and distributing PCR-based IVD tests, as well as exploring the latest regulatory requirements.

Presented by Dmitriy Kosarikov (bio)

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Non-Conformance and Corrective Action for Medical Device Manufacturers Training Course

Non-Conformance and Corrective Action for Medical Device Manufacturers

12 Dec 2024 - Online webinar
Also on: 10 Apr 2025

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.

Presented by Annette Callaghan (bio)

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

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

12 Feb 2025 - Online webinar
Also on: 5 Jun 2025

In this practical, one-day course, learn the regulatory requirements needed for successful post-market surveillance of medical devices and IVDs.

Presented by Anne Jury (bio)
Karen Pearson (bio)

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Practical Implementation of a Human Factors Study Training Course

Practical Implementation of a Human Factors Study

4-5 Mar 2025 - Online webinar
Also on: 1 Jul 2025

This training focuses on the practical and logistical aspects of planning, preparing and performing human factors studies for medical devices and combination products.

Presented by Richard Featherstone (bio)

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Pre-Filled Syringes: End-to-End Processing Training Course

Pre-Filled Syringes: End-to-End Processing

20-21 Mar 2025 - Online webinar
Also on: 21 Jul 2025

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.

Presented by Dale Charlton (bio)
Susanne Hall (bio)
Andreas Rothmund (bio)

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Process Validation for Medical Devices Training Course

Process Validation for Medical Devices

25-26 Feb 2025 - Online webinar
Also on: 5 Jun 2025

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.

Presented by Mustafa Edik (bio)

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Smart Packaging and Electronic Patient Information Training Course

Smart Packaging and Electronic Patient Information

13 Mar 2025 - Online webinar
Also on: 2 Jul 2025

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.

Presented by Graham Howieson (bio)

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Sterilization of Medical Devices Training Course

Sterilization of Medical Devices

3-4 Feb 2025 - Online webinar
Also on: 5 Jun 2025

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.

Presented by Annette Callaghan (bio)

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Sustainable Design and Manufacture for Medical Devices Training Course

Sustainable Design and Manufacture for Medical Devices

24 Mar 2025 - Online webinar
Also on: 3 Jul 2025

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.

Presented by Cormac O'Prey (bio)

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The Medical Device School - From Concept to CE Marking Training Course

The Medical Device School - From Concept to CE Marking

9-13 Jun 2025 - London

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.

Presented by Stuart Angell (bio)
and 7 more leading experts

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The Role of the Person Responsible for Regulatory Compliance (PRRC) Under the MDR (Medical Device Regulation) and IVDR (In-Vitro Diagnostic Regulation) Training Course

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

23 Jan 2025 - Online webinar
Also on: 22 May 2025

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.

Presented by Stuart Angell (bio)

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UK Conformity Assessed (UKCA) Marking for Medical Devices Training Course

UK Conformity Assessed (UKCA) Marking for Medical Devices

10 Feb 2025 - Online webinar
Also on: 26 Jun 2025

This course provides 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.

Presented by Janette Benaddi (bio)

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

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

5 Dec 2024 - Online webinar
Also on: 24 Mar 2025

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.

Presented by Annette Callaghan (bio)

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Very good course.

Richard Jones, Senior Medical Device Auditor, Eurofins E&E CML Limited

[Speaker] very experienced, knowledgeable and approachable. Webinar [was] prepared taking into account all of the participants with the general information as well as with the direct individual requirements in mind. Questions answered at the time as well as within time given after the webinar. Thank you.

Dorota Seweryn, Quality Engineer, First Water Ramsbury Limited

another excellant [sic] webinar from IPI

Toni Day, Global Director QARA, OrganOx Ltd

As the person responsible of safety assessment and reporting in my department (clinical), I was hoping to strengthen my knowledge in this area. Especially when it comes to event assessment and classification.
This course helped me achieve that goal. [Speaker] is very knowledgeable on several topics.

Stéphanie Trznadel, Clinical Trial Coordinator, SPINEART

Excellent conference, speaker, material etc were perfectly balanced and understandable.

Andrew Pearce, Corporate Quality & Regulatory Director, GVS

Koen is a great speak who explains things very clearly with examples

Yisong Yin, Software Regulatory Affairs Specialist, Convatec

Koen is a great speak who explains things very clearly with examples

Yisong Yin, Software Regulatory Affairs Specialist, Convatec

It was a good training for me and the speakers were well prepared and knowledgeable. The ppt's were also very up to date with recent info added on slides, also very nice to see that ppt's were available before training started.

Veerle Leijnen, Senior RA Executive Manager, Nikkiso Belgium

I got useful information.

Ravi Prabaharan, Research and Technology Manager, Advanced healthcare ltd

He's a real guru and he's also a very good teacher.

Juan Verde, MD, MSc, IHU Strasbourg