Presented by
Management Forum
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"
1-2 Aug 2022
- Format: Classroom
- CPD: 12 hours for your records
- Certificate of completion
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
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.
The Biological Evaluation of Medical Devices course will cover:
An introduction to medical devices
An introduction to biocompatibility
Biocompatibility vs biological safety
ISO 10993 history and development
ISO 10993 structure and content
ISO/TR 15499 and 10993/1 (2018)
Relationship between 10993 and 14971
Medical device categorisation for biological risk assessment
The move away from in vivo testing
Endpoints to be addressed in a biological risk assessment
Chemical characterisation vs chemical information
Physical characterisation
Guidance on technical aspects of specific biocompatibility tests
Extractables and leachables testing – when and why?
Risk assessment using E&L data
MDD safety requirements
MDR safety requirements
Good Laboratory Practice (GLP)
The 510(K) process
FDA’s take on ISO 10993
Japanese requirements
Chinese requirements
MDR – gap analysis of existing data
Change management – impact on biological risk assessment
Philip Clay
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.
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*
- GBP 1,299 1,499
- EUR 1,819 2,099
- USD 2,026 2,338
Until 27 Jun
- 2 days classroom-based training
- Meet presenters and fellow attendees in person
- Lunch and refreshments provided
- Download documentation and certification of completion
- Fair transfer and cancellation policy
* 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 
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
- BAUSCH & LOMB INC
- Bespak
- Biocompatibles UK Ltd
- BSI
- Cardinal Health
- Covidien
- Depuy CMW
- Dermal Laboratories Ltd
- Dyson
- Medigen Regulatory Limited
- MET Limited
- Pall Europe Limited
- QUINTILES CONSULTING - MTC
- 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
- SSL INTERNATIONAL
- Summit Medical Ltd
- Systagenix Wound Management
- Terumo
- Terumo Aortic
- Tissue Science Laboratories PLC
- University of Edinburgh
- Vernacare
- Xiros Ltd
Netherlands
- BioTop Medical
- Fresenius HemoCare Netherlands BV
- Mentor Medical Systems B.V.
- Merck Sharp & Dohme
- Omron Healthcare Europe BV
Denmark
- Denish Medical Devices Cert.
- LAB Research (Scantox)
- Novo Nordisk A/S
- William Cook Europe ApS
Ireland
- Abbott Vascular Devices Ireland
- Allergan Medical
- Cook Ireland Ltd
Sweden
- AstraZeneca AB
- Q-Med AB
- Wellspect Healthcare
Switzerland
- RCC LTD
- SCHOTT Schweiz AG
- Synthes GmbH
United States of America
- Cardinal Health
- DEPUY
Australia
- ITL LIMITED
Belgium
- Rousselot
Germany
- Angiomed GmbH & Co
Israel
- Elcam Medical ACAL
Italy
- Eurofins Biolab Srl
Pakistan
- ZAFA PHARMACEUTICALS (PVT) LTD
Run Biological Evaluation of Medical Devices Classroom for your team
2 days
Typical duration
Pricing from:
- GBP 800
- Per attendee
- 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 expert Aleksandra Beer to discuss your requirements:
