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The 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.

What is an Online Academy course? 

Online academy is a new online, interactive and engaging education tool designed to maximise learning for professionals with busy schedules and/or small training budgets.

The online academy brings alike professionals together and gives you the opportunity to share ideas and questions via the discussion forum creating your own professional community. Our on-demand feature means the content is available as and when you need it allowing greater flexibility to your professional development and learning.

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.

  • 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

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

What happens during an Online Academy course?


This online academy course can be accessed from 7 May 2019. 1 - 2 modules will be uploaded per week, allowing you to study at your own pace. Your trainer will welcome any questions that arise throughout your course.

Please note that full payment must be made prior to the course start date in order to receive your login details to begin the course.

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