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Biocompatibility Testing of Combination Devices – New Regulatory Guidance

November 3, 2016 | 8 a.m. PDT | 11 a.m. EDT | 3 p.m. GMT | 4 p.m. CET

Combination Devices WebinarAttend our webinar to learn how to implement an efficient testing program for assessing the biocompatibility of your combination product’s device component, which incorporates the relevant requirements of ISO 10993-1, to satisfy both U.S. and international regulatory agencies.

This presentation will include real-world case studies and best practices for:

  • Chemical Characterization, including Extractables and Leachables Testing
  • Toxicological Risk Assessments
  • Biocompatibility Testing
  • Pitfalls to avoid while developing testing plans
  • Future trends for Combination Products
  • Implications of new FDA guidance on the use of ISO 10993-1

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