The objective of the Seminar is to teach participants how to use the current ISO 10993-1 and FDA standards to establish a Biological safety evaluation plan, including how to document and implement their plan. Participants will not only learn how to assess their device for Biological risks but also understand when testing is not necessary. We will also cover how to properly document these findings and fill out a Biological evaluation report.
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 emphasize the use of risk-based approaches to assess Biocompatibility.
Course Content
- Risk-based approach to Biocompatibility evaluation strategy -
- Overview of current ISO 10993-1 and collateral standards Biocompatibility testing guidelines, costs, and turnaround times.
- Chemical characterization, leachables and extractables (L&E) testing, and toxicology assessments.
- Alternative testing to costly and time-consuming long-term animal testing.
Course Provider
Mike Colvin Ph.D,
Medical Device Technical Adviser/ConsultantMike has over 30 years’ experience developing medical devices and systems. Over his career he has been in charge of safety & efficacy testing and Regulatory & Clinical strategies. He has also served as a technical advisor/consultant in the medical device industry for over 25 years, giving him exposure to both large medical device companies and startups.
Mike has taught college for over 25 years and has contributed/participated on many domestic and international technical committees. He holds a Ph.D. in Physical Chemistry from the University of Southern California/California Institute of Technology.
Who Should Attend
- Anyone with a desire to be up to date with the current state of the art of Biocompatibility assessment.
- Medical device, pharmaceutical, and combination product start up and established companies.
