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Biological Evaluations

Biocompatibility

Biological evaluation of medical devices is an increasingly complex process, driven in large part by the growing influence of toxicologists in development of relevant standards (i.e, ISO 10993-1 and the underlying parts in the 10993 series). Chief among the emerging expectations from regulators has been heightened focus on chemical characterization with toxicological risk assessment for assessing biological safety.

Our regulatory scientists have deep experience in biological evaluation, gained from many years of participation in TC 194, the technical committee responsible for the ISO 10993 series of standards. Notably, our staff led the major revision of 10993-18, the international standard for chemical characterization of medical devices and their materials, and also participates in the ISO working groups currently revising the 10993 standards on sample preparation and toxicological risk assessment. Through years of effort in these processes, as well as practical application of these standards in support of numerous product submissions for market authorization, MED Institute has built a keen awareness of expectations from regulatory authorities for biological evaluations.

We can help you with your medical device development needs by providing you with the following expert biocompatibility services:

  • Guidance in approaches to evaluating safety of patient contacting materials and devices;
  • Development of biological evaluation plans (BEPs), including sample selection, biological testing, and extractables and leachables testing;
  • Review and analysis of available material information (e.g., knowledge of composition), history of use, and testing data to support material, chemical, and biological safety of your medical device;
  • Preparation or critical review of biological evaluation reports (BERs) and material and chemical characterization reports; and
  • Support for responding to questions from regulatory authorities on submitted biocompatibility data.

Whether you are having trouble deciding where to start, difficulty in understanding what testing may be needed for your product, or are struggling to address FDA biocompatibility deficiencies raised against data already submitted, we can help guide you.