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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

10-12 Nov 2021 - Online webinar
Also on: 8 Feb 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)
Janine Ingleby (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

1-2 Dec 2021 - Online webinar
Also on: 1 Feb 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

1-2 Nov 2021 - Online webinar
Also on: 10 Mar 2022

Practical guidance on borderline Issues and combination products

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

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Dry Powder Inhalers Training Course

Dry Powder Inhalers

9-10 Dec 2021 - London
Also on: 28 Jun 2022

A comprehensive overview of DPIs including market trends, treatments formulation, regulation and device design

*FULLY UPDATED PROGRAMME*

Presented by Mike Holroyd (bio)
David Howlett (bio)
Helen Muirhead (bio)

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

FDA Approval Process for Medical Devices

29-30 Mar 2022 - Online webinar
Also on: 15 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)

2-3 Nov 2021 - Online webinar
Also on: 19 May 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)

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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

8-9 Dec 2021 - Online webinar
Also on: 15 Jun 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

26-29 Oct 2021 - Online webinar
Also on: 25 Apr 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

19-20 Oct 2021 - Online webinar
Also on: 6 Apr 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 Medical Device Regulation Training Course

New Medical Device Regulation

12-13 Apr 2022 - Online webinar
Also on: 11 Jul 2022

Managing the transition to the new regulation: this is a seminar you cannot afford to miss as you put in place your strategies for the new environment.

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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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 Dec 2021 - Online webinar
Also on: 13 Jun 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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Richard was great. He made sure we were engaged at all times and was very conscientious that we were happy with what we were learning throughout and made it clear he was happy to tailor anything to fit our needs and expectations.

Georgia Rolland, Project Co-ordinator, Cambridge Design Partnership

Great speaker, flexible attitude, and inclusive.

Syeda Ameernaz, Clincal safety Physician, Novocure

A good and well thought out webinar with very intelligent presenter.

Ifesinachi Onyekaba, Research and Development Specialist, MEDTRON AG

Janette is very nice and friendly. She has a lot of relevant knowledge and experience about the clinical evaluation process and the report. I learned a lot form her!

Dror Sever, Senior Device Information Scientist, Novo Nordisk

I thought this was a terrific webinar, lead by an excellent topic expert, and I feel much more confident about participating and/or leading the CER update at my company.

Juliana Pugmire, Clinical Research Consultant, Current Health

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

It was overall a very good webinar that gave a nice overview of the Clinical Evaluation proces. A shame it had to be a webinar due to the Covid-19 situation, it would have worked better if we could all meet in person and also have small conversations in breaks and so on.

Christina Frary, research audiologist, Demant

Very informative

Shaun Phillips, Eng manager, Renfrew group