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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

★★★★★ "The course was very insightful and gave me a better understanding of the process and required effort... more (12)"

16-17 September 2024 »
from £1299

Need help?  Enrol or reserve

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 Chinese requirements

This course is of our range of Medical Devices training courses - now also including Medical Devices Cyber Security training to help improve your data security.

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:

  • 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

Enrol or reserve

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

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

16-17 September 2024

Rembrandt Hotel

09:00-17:00 UK (London)
Course code 13872
Optional £240/€312/$360 per night

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

Until 12 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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Not ready to book yet?

for 7 days, no obligation

* 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

The course was very insightful and gave me a better understanding of the process and required effort. Excellent and knowledgeable speaker.

Sep 18 2023

Lambert Luong
QA-officer, Enraf-Nonius B.V.

Sep 18 2023

Good training. I liked both the assessments and examples provided.

Sílvia Alexandra Fernandes
QA &RA Director, Nordeberg Medical AB

Sep 18 2023

My expectation were to understand the key steps of the processes and the challenges linked to each steps. It has been fully accomplished!

Cecile Artus-Arduise
Head of Medical Affairs, LABORATOIRE HRA PHARMA

Sep 18 2023

Very knowledgeable person, who knows how to involve the attendants and make the subject more tangible. The quizzes force you to rehearse, remember and also apply the information that was given during the course.

Anne-Marie van Maurik
QA-manager, Enraf-Nonius B.V.

Sep 18 2023

My expectation were to understand the key steps of the processes and the challenges linked to each steps. It has been fully accomplished! The training and the speaker were very great.

Cecile Artus-Arduise
Head of Medical Affairs, LABORATOIRE HRA PHARMA

Feb 8 2022

Excellent and very informative course

Anna Gabbott
Regulatory Affairs Specialist, Vernacare

Feb 8 2022

Excellent and very informative course

Anna Gabbott
Regulatory Affairs Specialist, Vernacare

Feb 8 2022

Very informative but also personalised

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

Feb 8 2022

Very detailed content and patient presenters

Elena Couzens
Service Development Manager, MET Limited

Feb 8 2022

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

Sarah Hinchliffe
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
Regulatory Affairs Manager, Elcam Medical ACAL

Oct 31 2019

It was a good course with good shared discussion about many topics and issues. The course material was well organized.

Elen Lasri
Regulatory Affairs Specialist, Elcam Medical ACAL

United Kingdom

  • Advanced Healthcare Ltd Unit 2-4
  • Altomed
  • AstraZeneca
  • Bedfont Scientific
  • Bespak
  • Biocompatibles UK Ltd
  • BSI
  • Cardinal Health
  • Covidien
  • CPI
  • Depuy CMW
  • Dermal Laboratories Ltd
  • Dyson
  • Haleon
  • Medigen Regulatory Limited
  • MET Limited
  • Pall Europe Limited
  • Ramsay MD-Regs Ltd
  • Renishaw plc
  • Russell Square Quality Associates Limited
  • Smith & Nephew Wound Management
  • Smiths Medical International Limited
  • Smiths Medical International Ltd
  • Sphere Medical Ltd
  • Summit Medical Ltd
  • Systagenix Wound Management
  • Terumo
  • Terumo Aortic
  • Tissue Science Laboratories PLC
  • University of Edinburgh
  • Vernacare
  • Xiros Ltd
  • Xiros plc


  • BioTop Medical
  • Enraf-Nonius B.V.
  • Fresenius HemoCare Netherlands BV
  • Mentor Medical Systems B.V.
  • Merck Sharp & Dohme
  • Omron Healthcare Europe BV


  • AstraZeneca AB
  • Glycorex Transplantation AB
  • Nordeberg Medical AB
  • Q-Med AB
  • Wellspect Healthcare


  • Denish Medical Devices Cert.
  • LAB Research (Scantox)
  • Novo Nordisk A/S
  • William Cook Europe ApS


  • Abbott Vascular Devices Ireland
  • Allergan Medical
  • Cook Ireland Ltd


  • SCHOTT Schweiz AG
  • Synthes GmbH

United States of America

  • Cardinal Health




  • Rousselot BV


  • Orion Corporation




  • Angiomed GmbH & Co


  • Elcam Medical ACAL


  • Eurofins Biolab Srl



Enrol or reserve

Run Biological Evaluation of Medical Devices Classroom for your team

2 days

Typical duration

Pricing from:

  • GBP 800
  • Per attendee, based on 10 attendees
  • Course tailored to your requirements
  • At your choice of location, or online


We can customise this course to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.

Contact our in-house training experts Aleksandra Beer and Yesim Nurko to discuss your requirements:

Multiple colleagues? See above for details of our discounts for 2, 3, or 4 delegates. For more, talk to one of our training experts to discuss how to:

Run this course conveniently and cost-effectively in-house for your staff and colleagues

Aleksandra Beer

Aleksandra BEER
Training expert

Yesim Nurko

Training expert

+44 (0)20 7749 4749