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

Frequently Asked Questions

  • Biocompatibility describes how a medical device interacts with human tissues and physiological systems. Evaluating it ensures that device materials are safe, non-toxic, and suitable for clinical use, protecting patients, and supporting regulatory compliance.

  • A Biocompatibility Gap Assessment identifies areas where existing safety data may be insufficient to demonstrate device biocompatibility. SciQra conducts these assessments to determine additional testing needs, ensuring complete and compliant safety evaluations under ISO 10993, FDA, and EU MDR requirements.

  • The selection of biocompatibility tests is driven by the type of body contact and duration of exposure. Modern regulators expect a risk-based approach, not a simple checklist. Collaboration with an experienced toxicologist ensures material data is properly evaluated, gaps are identified, and a fit-for-purpose testing strategy is designed to meet FDA, EU MDR, and global standards.

  • A Biological Evaluation Plan (BEP) outlines the strategy for demonstrating a device’s biological safety including hazards, testing rationale, and risk mitigation. The Biological Evaluation Report (BER) summarizes all test results, toxicological data, and risk assessments. Together, they form the backbone of ISO 10993, FDA, and EU MDR compliance.

  • Key challenges include navigating complex regulations, evolving ISO/MDR standards, and the need for complete, defensible data. SciQra helps clients navigate these challenges through toxicological risk assessments, BEP and BER preparation, ensuring devices are safe and compliant.