Biological Safety Evaluation: Using a Risk-Based Approach for Biocompatibility

Wednesday, June 12 10:30 AM - 1:30 PM

Location: Room 1

Event Information

Title: Biological Safety Evaluation: Using a Risk-Based Approach for Biocompatibility


This seminar summarizes how biocompatibility of medical devices is evaluated from a risk-based approach, based on the most recent feedback from FDA. The presentation focuses on the aspects most relevant to anyone who may influence the design, engineering, and quality assurance of devices. An introduction is given to the ISO 10993 standards and FDA guidance documents for medical devices as they apply to medical device manufactures. Focus is given to:

  • Biocompatibility risk analysis
  • How to use the risk analysis results for biocompatibility
  • FDA trends in approaches to biocompatibility testing
  • How chemistry is being used as an approach to biocompatibility
  • How to evaluate the impact of changes to biocompatibility

Understanding biocompatibility and associated testing is essential to all involved in the development and manufacture of medical devices. Issues that can be challenging for a final, finished device from a biocompatibility perspective may be easily prevented. Part of this seminar is in lecture format, while part is comprised of interactive, hands-on case studies.

Part 1 ISO 10993-1 Biocompatibility (Applying the New ISO 10993 Standards)

  • An overview of the new ISO 10993-1
  • Performing a Biological Evaluation Plan
  • Overview of the "Big Three" including new in vitro alternatives
  • What is needed in a Biological Evaluation Report for FDA?

Part 2 – ISO 10993-18 What is E&L and How to Evaluate Changes to Medical Devices

Extractable and Leachable testing (E&L) is becoming a regular part of biological evaluations. Although extremely helpful in a risk-based approach, uncertainties and irregularities between approaches hampers the tests full potential. This session will discuss:

  • What is the current regulatory status of E&L testing?
  • How can we make sure the regulatory bodies will accept our E&L studies?
  • If a material is changed, how is safety impacted?
  • If the change is small, is do you need to retest?
  • What if I change a manufacturing process, do you need to retest?

Part 3- MDRs Riding out the Storm

In the past, the CE mark process was smooth and quick and manufacturers often sought the CE mark first as an easier path to market. Suddenly, everything has changed. Today, manufacturers need to look at the implications of the changes in Europe (MDR), and the impact these changes bring to their commercial and marketing objectives.

  • What changes do the MDR bring and how much time do I have to comply?
  • Will Brexit impact my European submission?
  • What will my Notified Body be looking for with regard to the MDR?
  • Case study regarding different approaches

Level: All

Type: Sponsored Session