Biocompatibility Testing for Medical Devices
Medical Device Technical Adviser/Consultant
San Francisco, CA
Medical Device Technical Adviser/Consultant
The medical device field is one of the most heavily regulated industries, for obvious reasons. Medical devices are an important tool in efforts to improve patient care and treatment outcomes. Learn how to achieve more successful biocompatibility testing outcomes by attending this seminar.
Biocompatibility testing is in the spotlight with regulatory bodies – especially with the recent release of the updated European MDRs and the FDA’s Guidance document on ISO 10993-1. It is essential for medical device manufacturers to have an understanding of the current landscape for biocompatibility testing while keeping an eye on the future trends that will affect future requirements. This seminar will discuss the recent changes to regulatory documents and standards and how they will impact the overall biocompatibility assessment of medical devices.
Attendees will understand and apply ISO 10993-1 and the FDA Guidance on its use. They will know how to use the ISO documents to locate information that you need. Understand what tests to select and how to choose among various options.
By attending this seminar, attendees will get answers of these questions:
After completing this seminar, participants should be familiar with the full scope of ISO 10993-1, including the current version. The topics covered will include:
The areas that will be discussed in the seminar will include the following topics throughout the agenda:
Mike 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.
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