Biocompatibility Testing; what you need to know


Instructor: Mike Colvin
Product ID: 705585

  • Duration: 90 Min
This Webinar is geared toward those who require a working knowledge of biocompatibility.
Last Recorded Date: Jan-2018


1 Person Unlimited viewing for 6 month info Recorded Link and Ref. material will be available in My CO Section
(For multiple locations contact Customer Care)

Downloadable file is for usage in one location only. info Downloadable link along with the materials will be emailed within 2 business days
(For multiple locations contact Customer Care)



Customer Care

Fax: +1-650-362-2367

Email: [email protected]

Read Frequently Asked Questions

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.

The objective of the Webinar is to teach participants how to use 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.

Areas Covered in the Webinar:

  • 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
  • Time-consuming long-term animal testing

Who Will Benefit:

  • Regulatory affairs professionals
  • Compliance Managers
  • Quality Managers
  • Manufacturing Engineers
  • Research and Development
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.

Follow us :



Refund Policy

Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).




6201 America Center Drive Suite 240, San Jose, CA 95002, USA

Follow Us

facebook twitter linkedin youtube


Copyright © 2023 MetricStream
Our Policies: Terms of use | Privacy

PAYMENT METHOD: 100% Secure Transaction

payment method