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Fundamentals of Biocompatibility for Medical Devices

4-weeks | 2 hours per week

3 August - 4 September 2020

Online Academy

Within medical devices, biocompatibility assessments are essential in the early stages of development to safeguard patient safety. Notified Bodies must see adequate data on biocompatibility (in accordance with ISO 10993) to be sure a device is biologically safe.

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

If you would like to start the course sooner than advertised simply get in contact with our training consultants by emailing and we will arrange this for you as soon as possible.

  • 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.

Download the digital training guide.

Watch the Online Academy Video

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