Biocompatibility Testing; what you need to know

Attend this webinar to learn how to use ISO 10993-1 and FDA standards to establish a biological safety evaluation plan, how to implement the plan, how to assess your device for biological risks and when testing is not required.

Recorded Version Only

(PPT + Recorded Streaming Link)

$249.00
1x Person - Unlimited viewing for 6 Months (For multiple locations contact Customer Care)
rec Recorded Link and Ref. material will be available in My Account Section
Last Recorded Date: Sep-2019

CD or USB Drive Only

(PPT + Recorded Training File)

$349.00
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(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days
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Why Should You Attend:

Any medical device that directly or indirectly contacts human body is required to be assessed for biocompatibility of the materials used in the manufacture of the device, with the test schedule based on the nature and duration of body contact. The regulatory agencies, both domestic and international encourage Risk-based approaches to assess biocompatibility rather than following the specified testing matrix.

In this webinar, you will learn how to use ISO 10993-1 and FDA standards to establish a biological safety evaluation plan, how to implement the plan, how to assess your device for biological risks and when testing is not required.

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.

Refund Policy

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. FDATrainingAlert 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.

If you have any concern about the content of the webinar and not satisfied 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 customercare@fdatrainingalert.com call +1-888-771-6965 (Toll Free).

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