ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process

12:00 PM ET | 9:00 AM PT | 11:00 AM CT Duration 90 Minutes

Webinar Includes : All the training handouts , Certificate by the Speaker ,Q/A and 90 Min Live Webinar

"Listen From Mike Colvin Ph.D have over 100 domestic and International patents issued."

Overview of ISO 10993-1

Description

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.   

Areas Covered

•      Risk-based approach to Biocompatibility evaluation strategy. 
•      Overview of  ISO 10993-1. 
•      Biocompatibility testing guidelines, costs, and turnaround times.  
•    Leachables and extractables (L&E) testing as an alternative to costly and time-consuming long-term animal testing.

Who will Benefit

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

Industries who can attend

This 90-minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.


Speaker Profile

Mike Colvin Ph.D.

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 start ups.

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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