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In-house & bespoke training:
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

In-house & bespoke training

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

Rated by attendees to the public programme

Typically presented by Janette Benaddi (bio) , Theresa Jeary (bio)

Typical duration: 2 days
Pricing from £800 per attendee
Delivery: collaborative classroom

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An Introduction to the Design and Development of Medical Devices

In-house & bespoke training

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

Rated by attendees to the public programme

Typically presented by David Howlett (bio)

Typical duration: 2 days
Pricing from £800 per attendee
Delivery: collaborative classroom

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An Introduction to the Medical Device Regulation

In-house & bespoke training

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.

Rated by attendees to the public programme

Typically presented by Janette Benaddi (bio) , Will Burton (bio) , Theresa Jeary (bio)

Typical duration: 3 days
Pricing from £1,200 per attendee
Delivery: collaborative classroom

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Biological Evaluation of Medical Devices

In-house & bespoke training

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

Rated by attendees to the public programme

Typically presented by Philip Clay (bio) , Janine Ingleby (bio)

Typical duration: 2 days
Pricing from £800 per attendee
Delivery: collaborative classroom

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Brexit Webinar - Impact on Pharmaceutical / Medical Devices Industries

In-house & bespoke training

Brexit Update - What will happen next?
14.15 (GMT)

Rated by attendees to the public programme

Typical duration: 1 day
Pricing from £450 per attendee
Delivery: collaborative classroom

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Clinical Evaluation of Medical Devices: The Clinical Evaluation Report

In-house & bespoke training

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

Rated by attendees to the public programme

Typically presented by Janette Benaddi (bio)

Typical duration: 2 days
Pricing from £800 per attendee
Delivery: collaborative classroom

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Cyber Security for Medical Devices

In-house & bespoke training

Rated by attendees to the public programme

Typical duration: 2 days
Pricing from £800 per attendee
Delivery: collaborative classroom

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

In-house & bespoke training

Practical guidance on borderline Issues and combination products

Rated by attendees to the public programme

Typically presented by Tina Amini (bio)
and 3 more leading experts

Typical duration: 2 days
Pricing from £800 per attendee
Delivery: collaborative classroom

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Dry Powder Inhalers

In-house & bespoke training

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

*FULLY UPDATED PROGRAMME*

Rated by attendees to the public programme

Typically presented by Mike Holroyd (bio) , David Howlett (bio) , Helen Muirhead (bio)

Typical duration: 2 days
Pricing from £800 per attendee
Delivery: collaborative classroom

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EC Medical Devices Vigilance System and Post Marketing Surveillance

In-house & bespoke training

This conference provides a unique opportunity to meet competent authorities, notified bodies, lawyers, consultants and manufacturers to understand and discuss the regulatory and legal requirements with respect to post-marketing surveillance including vigilance.

Rated by attendees to the public programme

Typical duration: 2 days
Pricing from £800 per attendee
Delivery: collaborative classroom

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FDA Approval Process for Medical Devices

In-house & bespoke training

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.

Rated by attendees to the public programme

Typically presented by Jonathan Hughes (bio)

Typical duration: 2 days
Pricing from £800 per attendee
Delivery: collaborative classroom

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

In-house & bespoke training

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.

Rated by attendees to the public programme

Typically presented by Richard Featherstone (bio)

Typical duration: 2 days
Pricing from £800 per attendee
Delivery: collaborative classroom

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Impact of the Medical Device Regulation (MDR)

In-house & bespoke training

Are you prepared and what next?

14.00 (GMT)

Typical duration: 1 day
Pricing from £450 per attendee
Delivery: collaborative classroom

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Inhaled Drug Delivery

In-house & bespoke training

An essential annual update for inhalation professionals.

Rated by attendees to the public programme

Typical duration: 2 days
Pricing from £800 per attendee
Delivery: collaborative classroom

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Introduction to the In-Vitro Diagnostic Regulation (IVDR)

In-house & bespoke training

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.

Rated by attendees to the public programme

Typically presented by Stuart Angell (bio)

Typical duration: 2 days
Pricing from £800 per attendee
Delivery: collaborative classroom

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ISO 13485: Quality Management Systems for Medical Devices

In-house & bespoke training

Compare the requirements of ISO 13485 and ISO 9001, understand the role and responsibilities of quality management. Consider the relationship between ISO 13485 and ISO 14971 'Application to Risk Management to Medical Devices'.

Rated by attendees to the public programme

Typical duration: 2 days
Pricing from £800 per attendee
Delivery: collaborative classroom

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

In-house & bespoke training

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.

Rated by attendees to the public programme

Typically presented by Anna Harrington-Morozova (bio)

Typical duration: 2 days
Pricing from £800 per attendee
Delivery: collaborative classroom

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Medical Device Regulations in Asia-Pacific Markets

In-house & bespoke training

Gain practical advice on how regulations are being applied to enable you to take full advantage of this rapidly growing market.

Typical duration: 2 days
Pricing from £800 per attendee
Delivery: collaborative classroom

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Medical Device Regulations in the Middle East and North Africa

In-house & bespoke training

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

Rated by attendees to the public programme

Typically presented by Heba Hashem (bio) , Ilona Putz (bio)

Typical duration: 2 days
Pricing from £800 per attendee
Delivery: collaborative classroom

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

In-house & bespoke training

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

Rated by attendees to the public programme

Typically presented by Koen Cobbaert (bio) , Zuzanna Kwade (bio)

Typical duration: 3 days
Pricing from £1,200 per attendee
Delivery: collaborative classroom

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Medical Device Studies: Clinical Evidence

In-house & bespoke training

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

Rated by attendees to the public programme

Typically presented by Janette Benaddi (bio)

Typical duration: 2 days
Pricing from £800 per attendee
Delivery: collaborative classroom

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Medical Device Studies: Regulatory Requirements and Adverse Event Reporting

In-house & bespoke training

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

Rated by attendees to the public programme

Typically presented by Janette Benaddi (bio)

Typical duration: 2 days
Pricing from £800 per attendee
Delivery: collaborative classroom

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Medical Writing for Medical Devices

In-house & bespoke training

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

Rated by attendees to the public programme

Typically presented by Janette Benaddi (bio) , Barbara Grossman (bio)

Typical duration: 2 days
Pricing from £800 per attendee
Delivery: collaborative classroom

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Metered Dose Inhaler (MDI) Technology

In-house & bespoke training

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

Rated by attendees to the public programme

Typically presented by David Howlett (bio)

Typical duration: 2 days
Pricing from £800 per attendee
Delivery: collaborative classroom

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Nasal Drug Delivery

In-house & bespoke training

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

Rated by attendees to the public programme

Typically presented by Michael Benninger (bio)
and 12 more leading experts

Typical duration: 2 days
Pricing from £800 per attendee
Delivery: collaborative classroom

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New Medical Device Regulation

In-house & bespoke training

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.

Rated by attendees to the public programme

Typically presented by Janette Benaddi (bio) , Theresa Jeary (bio) , David Jefferys (bio)

Typical duration: 2 days
Pricing from £800 per attendee
Delivery: collaborative classroom

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Pre-Filled Syringes: End-to-End Processing

In-house & bespoke training

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.

Rated by attendees to the public programme

Typically presented by Dale Charlton (bio) , Andreas Rothmund (bio) , Patrik Thoma (bio)

Typical duration: 2 days
Pricing from £800 per attendee
Delivery: collaborative classroom

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Technical Documentation to Comply with the MDR and IVDR

In-house & bespoke training

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.

Rated by attendees to the public programme

Typically presented by Will Burton (bio) , Paul Sim (bio)

Typical duration: 2 days
Pricing from £800 per attendee
Delivery: collaborative classroom

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The end of the Brexit Transition Period – Impact on Medical Device Industry

In-house & bespoke training

The very latest information and operational experiences to be shared.

90 minute live webinar
14:00 (UK/London Time Zone)

Rated by attendees to the public programme

Delivery: collaborative classroom

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The Medical Device School - From Concept to CE Marking

In-house & bespoke training

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.

Rated by attendees to the public programme

Typically presented by Janette Benaddi (bio)

Typical duration: 5 days
Pricing from £1,500 per attendee
Delivery: collaborative classroom

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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