Medical Devices

Preparation of Biological Evaluation Plan (BEP), Biological Evaluation Report (BER), and Toxicological Risk Assessment (TRA) for extractables and leachables is one of our key services. Our fundamental understanding of chemistry and toxicology gives us an edge in evaluating a wide range of chemicals. We can help address inquiries from regulatory agencies in the US and EU based on ISO 10993, ICH M7, and EU MDR guidance. By providing expert toxicological evaluation, we ensure that our clients' medical devices are safe for use and compliant with regulatory requirements.

Our services:

  • Biological Evaluation Plan (BEP) for MDR/FDA submission

  • Biological Evaluation Report (BER) for a wide range of medical devices

  • Toxicological Risk Assessment (TRA) report of extractables and leachables

  • TI/TE reports for the identified extractables and leachables

  • Hazard summary preparation for various chemical ingredients used in medical devices

  • Biocompatibility gap assessments according to the ISO 10993 and FDA standards

  • Protocol design for biocompatibility studies

  • Test selection, material characterization, and solvent selection per ISO 10993

Medical-Devices-Toxicological-Risk-Assessment