Biological Safety Evaluation Plan, Risk Assessment and Evaluation Report


Instructor: Mike Colvin
Product ID: 705786
Training Level: Basic and Intermediate

  • Duration: 90 Min
The objective of the Webinar is to teach participants how to use ISO 10993-1 and FDA guidance to establish a proper biological safety evaluation plan, including how to document and implement their plan. It will also cover how to properly complete your biological evaluation report including biological safety assessment as required by domestic and foreign regulatory submissions.
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Why Should You Attend:

All medical devices that have direct or indirect contact with the human body require an assessment of the biocompatibility of the materials used to manufacture the device, with the test schedule depending on the nature and duration of body contact. Domestic and international regulatory bodies are encouraging the use of risk-based approaches to assess biocompatibility rather than strictly following the specified testing matrix. A biological test plan, assessment, and report are required.

Attend this webinar to acquire a working knowledge on how to properly prepare a biological evaluation plan and report and understand Risk-based approach to Biocompatibility evaluation, testing, safety assessment.

Areas Covered in the Webinar:

  • Risk-based approach to Biocompatibility evaluation strategy.
  • Overview of ISO 10993-1.
  • Biocompatibility testing guidelines.
  • Preparing a biological evaluation report.
  • Leachables and Extractables (L&E) testing.
  • Biocompatibility safety assessment.
  • Preparing a biological evaluation report.
  • What needs to be in the plan and report?

Who Will Benefit:

Anyone with a desire to be up to date with the current state of the art of Biocompatibility assessment.

  • R&D
  • Regulatory
  • Compliance Staff
  • Managers
  • Quality Personnel
Instructor Profile:
Mike Colvin

Mike Colvin
Medical Device Technical Adviser/Consultant

Dr. Mike Colvin has over 30 years direct experience in managing Biocompatibility assessment and testing, working in the medical device and combination products field. He has worked on/contributed to many domestic and international Biocompatibility committees, and has been a consultant to the medical device industry on the proper Biocompatibility strategies for success.

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