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Biological Evaluation of Medical Devices Training Course

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

★★★★★ "Excellent and very informative course"

18-19 September 2023

Need help? Enrol or reserve

Format: Classroom
CPD: 12 hours for your records
Certificate of completion

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Course overview

The ISO 10993 series of standards covering biological evaluation of medical devices is well established and regulatory authorities worldwide expect compliance. In Europe, compliance with the standards is the easiest way to meet the essential product safety requirements of the MDR and understanding a risk management approach to biological safety is essential.

This seminar will provide key guidance on how to use the standards and successfully apply a risk management approach to the biological evaluation of medical devices. There will be plenty of time during the programme for interactive discussion with experts in this field.

Benefits of attending:

Understand biological risk management
Clarify the requirements of ISO 10993-1
Learn what endpoints need to be addressed in a biological risk assessment
Establish how much chemical characterisation is necessary
Hear the FDA’s approach to ISO 10993
Better understand Medical Device Directive (MDD) safety requirements vs the Medical Device Regulation (MDR) safety requirements
Know how extractables and leachables impact on medical device safety
Discuss the Japanese and Chineserequirements

This course is part of our Regulatory Affairs Training course collection, which features updates on the latest regulations to registration procedures and strategies.

Who should attend?

The event will be of particular importance to those in the medical device industry from the following departments:

Regulatory affairs
R&D
Product safety/toxicology
Analytical chemistry
Risk assessment and risk management
Materials research and evaluation

It will also be of interest to regulatory authorities, Notified Bodies and CROs supporting the medical device industry.

Enrol or reserve

The Biological Evaluation of Medical Devices course will cover:

Day 1
Day 2

An Introduction to Biological Evaluation

Overview of Biocompatibility

ISO 10993 History and Development / ISO 10993 Structure and Content

Relationship Between Regulatory Standards

Impact of MDR

Impact of Brexit

Gap Analysis of Existing Biocompatibility Data

Medical Device Categorisation for Biological Risk Assessment + Practical Exercise

Endpoints to be Addressed in a Biological Risk Assessment

GLP Requirements

Lab Selection

Physical and Chemical Characterisation

Extractables and Leachables Testing - when and why? + Practical Exercise

Use of QSAR

Use of Data Sources to and Literature Searching

Change Management

International Requirements

Gas Pathway Devices + Practical Exercise

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Philip Clay
Chorley Consulting

Philip Clay is Director and principal toxicologist with Chorley Consulting. He is a UK and European registered toxicologist and specialises in product safety assessment with over 30 years’ experience in toxicology and safety assessment. He is a BSI committee member on CH/194 (Biological evaluation of medical devices) and Principal Expert for WG6 (Mutagenicity, carcinogenicity and reproductive toxicity).
Philip established his reputation as a genetic toxicologist working within the agrochemical, chemical and pharmaceutical industries. He has contributed to many expert panels, helping to shape the testing guidelines and strategies in place today. More recently, this experience and depth of understanding has been applied to designing safety assessment programmes for medical devices and consumer healthcare products for a wide range of clients. Philip is presently a member of a Consumer Healthcare Products Association (CHPA) expert group lobbying US FDA regarding the use of in vitro data in the assessment of the biocompatibility of medical devices.
He has extensive experience in the biological safety evaluation of a wide range of medical devices from Class 1 consumer healthcare devices through to Class 3 implantable devices. He is an experienced speaker at scientific conferences and has delivered training on biological safety evaluation around the world.

More details

Rona Middlemiss
Chorley Consulting

Rona is a Senior Safety Assessor with Chorley Consulting. She holds a first class MSci in Biomedical Sciences from the University of Aberdeen. Additionally, she has attended training courses on the Practical Application of Toxicology in Drug Development and also Personal Animal License Course, Modules 1-3. She spent her year industry with a multinational consumer healthcare and medical device manufacturer, gaining experience in the safety assessment of medical devices. She joins Chorley from a Scientist role with British American Tobacco where she honed her toxicology skills performing toxicological risk assessment for harm reduction products. Rona brings to Chorley experience gained with a healthcare medical device manufacturer as well toxicological risk assessment skills gained during her time with BAT.

During her time with Chorley, Rona has rapidly developed her skills in performing toxicological risk assessments of extractable and leachable data including the use of in silico tools for the prediction of toxicological effects. She has also developed her presentation skills, having presented a number of on-line training modules around various aspects of Biological Evaluation of Medical Devices.

More details

Book Biological Evaluation of Medical Devices Classroom training

NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:

30% off the 2nd delegate*
40% off the 3rd delegate*
50% off the 4th delegate*

Please contact us for pricing if you are interested in booking 5 or more delegates

18-19 September 2023

Classroom
Rembrandt Hotel
London

09:00-17:00 UK (London)
Course code 12279
Optional £235/€335/$385 per night

GBP 1,299 1,499
EUR 1,869 2,149
USD 2,137 2,449

Until 14 Aug

2 days classroom-based training
Optional accommodation - 2 nights including breakfast, checking in the day before the course
Meet presenters and fellow attendees in person
Lunch and refreshments provided
Download documentation and certification of completion
Fair transfer and cancellation policy

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* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price.

Reviews of IPI's Biological Evaluation of Medical Devices training course

Excellent and very informative course

Feb 8 2022

Anna Gabbott United Kingdom
Regulatory Affairs Specialist, Vernacare

Feb 8 2022

Excellent and very informative course

Anna Gabbott United Kingdom
Regulatory Affairs Specialist, Vernacare

Feb 8 2022

Very informative but also personalised

Paul Fineran United Kingdom
Healthcare Technology Portfolio Project and Development Manager, University of Edinburgh

Feb 8 2022

Very detailed content and patient presenters

Elena Couzens United Kingdom
Service Development Manager, MET Limited

Feb 8 2022

the course was well presented and clear enough for a complete beginner to understand.

Sarah Hinchliffe United Kingdom
Microbiology Manager, Xiros Ltd

Oct 31 2019

I learned a lot from this course, the speakers were great and they encouraged questions from the attendees. The quiz summarized each part well. My overall opinion is very positive and I would recommend it to my colleagues.

Avital Levertov Israel
Regulatory Affairs Manager, Elcam Medical ACAL