MDTI is part of the Knowledge & Networking Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 3099067.

Informa

Fundamentals of Biocompatibility for Medical Devices

4-weeks | 2 hours per week

7 May - 2 June 2019

Online Academy

The ISO 10993 standards are used by medical device manufacturers for the evaluation of biological safety testing, and in late 2018 they were updated to adopt a more risk-based approach to biocompatibility testing.

Over four weeks this course will provide you with a baseline understanding of the key changes to ISO 10993 and what you need to include in an evaluation under the new requirements. In addition, you will be able to understand biocompatibility in the context of risk management, the MDR safety requirements and from a global perspective, cemented by a series of case studies.

  • Understand the relationship between biocompatibility testing and ISO 14971
  • Analyse ISO 10993-1 and its updates
  • Explore material characterisation in its different forms
  • Examine the MDR safety requirements in the context of biocompatibility
  • Recognise the differences in the EU MDR and FDA 510(k) approaches
  • Review the relevant End Points for Consideration

Philip Clay

Philip Clay is Director and principal toxicologist with Chorley Consulting. He is a registered toxicologist and specialises in product safety assessment with over 30 years’ experience. He has published and presented widely in his expert field of genetic toxicology and in the wider area of safety assessment. 

Phillip has recently joined the BSI Ch/194 Committee to provide UK input to ISO/Tc 194 and CEN/TC 206 for standards relating to biological evaluation of medical devices.


This course will be useful for anyone new to biocompatibility for medical devices, who would like a refresher of this material or to update their understanding of regulations, including:

  • Regulatory Affairs
  • Quality Assurance
  • Manufacturing, development and design
  • Toxicology
  • Process development

MDTI online academies are perfect for busy professionals as they require just 2 hours per week of your time, and include an interactive forum for you to ask direct questions about challenges you are facing to expert course leaders.


Modules are released on a weekly basis so you can pace yourself alongside your peers and you will have access to a comprehensive set of assets to support your learning such as video content, quizzes and case studies.

Watch the Online Academy Video

You may also be interested in...

Fundamentals of Risk Management for Medical Devices
4-weeks | Online | Starts 4 March 2019

Understanding Biocompatability for Medical Devices
2-days | London | Starts 21 May 2019

Navigating the Regulations for Health Apps and Medical Device Software
4-weeks | Online | Starts 4 March 2019

Medical Device Regulations in Russia
4-weeks | Online | Starts 4 March 2019