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Training courses & Webinars:
Medical Devices

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, Management Forum 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.

 

Advanced Regulatory Affairs for Medical Devices Training Course

Advanced Regulatory Affairs for Medical Devices

1-2 Mar 2022 - Online webinar
Also on: 27 Sep 2022

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 Introduction to the Design and Development of Medical Devices Training Course

An Introduction to the Design and Development of Medical Devices

5-6 Apr 2022 - Online webinar
Also on: 4 Jul 2022

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

18-20 May 2022 - Online webinar
Also on: 1 Aug 2022

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

8-9 Feb 2022 - London
Also on: 1 Aug 2022

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

4-5 May 2022 - Online webinar
Also on: 8 Aug 2022

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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Drug/Device and Device/Drug Combinations in the EU (European Union) and USA Training Course

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

10-11 Mar 2022 - Online webinar
Also on: 7 Jun 2022

Practical guidance on borderline Issues and combination products

Presented by Tina Amini (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

23-24 Mar 2022 - Online webinar
Also on: 22 Jun 2022

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

8-9 Mar 2022 - Online webinar
Also on: 14 Sep 2022

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)

19-20 May 2022 - Online webinar
Also on: 3 Nov 2022

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)
Nancy Consterdine (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

12-13 Apr 2022 - Online webinar
Also on: 5 Jul 2022

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

15-16 Jun 2022 - Online webinar
Also on: 20 Sep 2022

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 Software: Complying with the EU (European Union) MDR (Medical Device Regulation), EU (European Union) IVDR (In-Vitro Diagnostic Regulation) & FDA (Food and Drug Administration) Regulations Training Course

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

25-28 Apr 2022 - Online webinar
Also on: 4 Jul 2022

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

9-10 May 2022 - Online webinar
Also on: 15 Aug 2022

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

9-10 Mar 2022 - Online webinar
Also on: 7 Jun 2022

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

6-7 Apr 2022 - Online webinar
Also on: 5 Jul 2022

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

31 Mar-1 Apr 2022 - Online webinar
Also on: 20 Jun 2022

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

Presented by David Howlett (bio)

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Nasal Drug Delivery Training Course

Nasal Drug Delivery

26-27 Apr 2022 - Online webinar
Also on: 4 Oct 2022

A comprehensive review of the latest scientific developments, technology advances and regulatory guidance in the field of nasal drug delivery.

Presented by Michael Benninger (bio)
and 12 more leading experts

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New Regulations for Medical Devices and IVDs in Europe Training Course

New Regulations for Medical Devices and IVDs in Europe

24-25 Feb 2022 - Online webinar
Also on: 13 Oct 2022

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.

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

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

Pre-Filled Syringes: End-to-End Processing

30-31 Mar 2022 - Online webinar
Also on: 21 Sep 2022

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)
Andreas Rothmund (bio)
Patrik Thoma (bio)

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SMART Packaging and Electronic Patient Information Training Course

SMART Packaging and Electronic Patient Information

17 Mar 2022 - Online webinar
Also on: 13 Jul 2022

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). These technologies have grown in importance providing patients and medical staff with product data, reminders, healthcare delivery and diagnostic tools.

Presented by Christopher Waterhouse (bio)

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Technical Documentation to Comply with the MDR (Medical Device Regulation) and IVDR (In-Vitro Diagnostic Regulation) Training Course

Technical Documentation to Comply with the MDR and IVDR

25-26 May 2022 - Online webinar
Also on: 22 Nov 2022

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.

Presented by Will Burton (bio)
Paul Sim (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

13-17 Jun 2022 - Online webinar
Also on: 5 Dec 2022

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 Janette Benaddi (bio)

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The presenter was pleasant, knowledgeable and helpful. The participants all contributed a lot and there was good interaction. The presentation was well-paced.

Fiona Broderick, Senior Medical Writer, Norgine

10 out of 10! Loved the polling option - it kept me engaged.. Presentations were very helpful and informative.

Angelina Barfield, Director, Safety Reporting, IQVIA Biotech

I thought the presentations were good, Janette in particular, some courses will just read what's on the slides, but this training had a lot of discussion and supplementary info which wasn't necessarily written word for word on the slides, so great presentation style. Very useful.

Scott Waterson, Senior Quality Engineer, Teva Pharmaceuticals

Topics very interesting and up to date. Speakers very good and their speeches were understandable.
Questions were welcomed and all this created a good atmosphere in the webinar and between participants and speakers. Very good!

Arberite Mjaku, , TEOXANE SA

Lived up to my expectations with respect to content. Nice presentation, and the speakers really knew everything about the IVDR.

Lena Vang, R&D Senior Specialist, Design Verification, Radiometer Medical

Good course

Evie Eccles, Quality Assurance and Regulatory Compliance Manager, Blackford

The course covered a vast area, and it was helpful to follow new requirements/changes.

Jitendra Gupta, International Medical Manager, Novo Nordisk A/S

All round excellent score. David was very clear with his diction and could not be faulted. He clearly has vast knowledge and experience in this field.

Christopher Thorpe, Junior Engineer, Osler Diagnostics

David was very knowledgeable about the course content, and was able to answer all questions put to him throughout the course. David did well to deliver the training via the webinar.

Richard Arthur, Quality Engineer, Occuity

This training provided a comprehensive view of what is expected from regulators. [Richard] paid attention to speak clearly (appreciated from not-native English speakers) and was attentive to the participants.

Emmanuelle Tourte, Head of Regulatory Compliance & Data Management, Guerbet