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

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

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

4 Jun 2024 - Online webinar
Also on: 5 Dec 2024

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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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 2024 - Online webinar
Also on: 22 Oct 2024

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

4-7 Jun 2024 - Online webinar
Also on: 7 Oct 2024

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

8-9 Jul 2024 - Online webinar
Also on: 8 Nov 2024

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

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

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

24 Apr 2024 - Online webinar
Also on: 10 Jul 2024

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 (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

21 May 2024 - Online webinar
Also on: 18 Nov 2024

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

4 Jul 2024 - London
Also on: 20 Nov 2024

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 Stuart Angell (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

22-23 Apr 2024 - Online webinar
Also on: 24 Jul 2024

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

15-17 May 2024 - Online webinar
Also on: 31 Jul 2024

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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Biological Evaluation of Medical Devices Training Course

Biological Evaluation of Medical Devices

16-17 Sep 2024 - London

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 Philip Clay (bio)
Rona Middlemiss (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

9-10 May 2024 - Online webinar
Also on: 5 Aug 2024

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

20-21 Jun 2024 - Online webinar
Also on: 14 Oct 2024

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

2-3 May 2024 - Online webinar
Also on: 4 Jul 2024

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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Delivery of Biologics to the Nasal Cavity Training Course

Delivery of Biologics to the Nasal Cavity

4 Jun 2024 - Online webinar
Also on: 8 Oct 2024

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.

Presented by Irene Rossi (bio)
and 3 more leading experts

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

FDA Approval Process for Medical Devices

19-20 Jun 2024 - Online webinar
Also on: 10 Sep 2024

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 Jun 2024 - London
Also on: 17 Sep 2024

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.

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)

24-25 Jul 2024 - Online webinar
Also on: 5 Nov 2024

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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Managing Competence within the Medical Device Industry Training Course

Managing Competence within the Medical Device Industry

1 May 2024 - Online webinar
Also on: 5 Nov 2024

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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Masterclass: Artificial Intelligence-based Medical Devices Training Course

Masterclass: Artificial Intelligence-based Medical Devices

26 Jul 2024 - Online webinar
Also on: 7 Nov 2024

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.

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

16-19 Apr 2024 - Online webinar
Also on: 2 Jul 2024

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

11-12 Jun 2024 - Online webinar
Also on: 7 Oct 2024

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)

4-5 Jul 2024 - Online webinar
Also on: 28 Nov 2024

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

22-25 Apr 2024 - Online webinar
Also on: 22 Jul 2024

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

10-11 Jul 2024 - Online webinar
Also on: 11 Nov 2024

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

21-22 May 2024 - Online webinar
Also on: 16 Sep 2024

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

1-2 Jul 2024 - Online webinar
Also on: 21 Nov 2024

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

20-21 Jun 2024 - Online webinar
Also on: 9 Oct 2024

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

Presented by David Howlett (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

19 Jun 2024 - Online webinar
Also on: 12 Dec 2024

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

6 Jun 2024 - Online webinar
Also on: 10 Oct 2024

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.

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

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

Pre-Filled Syringes: End-to-End Processing

25-26 Jul 2024 - Online webinar
Also on: 6 Nov 2024

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)
and 3 more leading experts

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Process Validation for Medical Devices Training Course

Process Validation for Medical Devices

5-6 Jun 2024 - London
Also on: 15 Oct 2024

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.

Smart Packaging and Electronic Patient Information Training Course

Smart Packaging and Electronic Patient Information

10 Jul 2024 - Online webinar
Also on: 4 Nov 2024

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.

Presented by Graham Howieson (bio)

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Sterilization of Medical Devices Training Course

Sterilization of Medical Devices

6-7 Jun 2024 - Online webinar
Also on: 17 Oct 2024

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

25 Apr 2024 - Online webinar
Also on: 4 Jul 2024

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.

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

10-14 Jun 2024 - London
Also on: 2 Dec 2024

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

21 May 2024 - London
Also on: 24 Sep 2024

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

15 Jul 2024 - Online webinar
Also on: 19 Nov 2024

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.

Presented by Janette Benaddi (bio)

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Koen has a breadth and depth of experience in this area, and was great at sharing that in an very accessible manner.

Michelle Galea, External Projects Manager, Optos plc

It was very organized and beautifully presented

Tena Green, Medical Writer/Clinical Consultant, SunMed, LLC

I enjoyed the structure and the way the webinar is organized with a very knowledgeable and interesting speaker.

Emina Omeragic, Director Clinical Regulatory Affairs, TRiCares GmbH

I am brand new to the CER world and was hoping to better understand the layout. Janette did a fantastic job helping me to accomplish this. She made it very easy to get a clear picture of the expectations of completing a CER.

Tena Green, Medical Writer/Clinical Consultant, SunMed LLC

Very kind and attentive

Nicolas Oviedo, Medical Affairs Specialist, Baxter Healthcare Corp

Excellent, it was very interesting and I find the speaker very knowledgeable.

Kolbrun E Ottosdottir, , Nox Medical

My goal was to gain an overview on the regulations on medical devices and the general procedure of clinical evaluations. This goal has been achieved.

Hoda Bazafkan, Clinical Evaluations Manager, Geräte GmbH

The material was very informative and presented by David in a way that was easy to understand, with good diagrams and analogies that helped with the understanding. Good balance of the technical aspects, history and options for the future.

Simon Barton, Director - Device CoE, AstraZeneca

The training was clear and comprehensive.

Alexandre Jauniaux, Head of division, Federal Agency for Medicines and Health Products

Very passionate and answered questions clearly

Genn Kamei, , Nox Medical