Medical Device Biological Evaluation Plan, Report, and Strategy Consulting

Biological Evaluation Reports (BER)

As part of a Biological Evaluation Report, NAMSA’s biological safety experts perform an overall evaluation of a device/family of devices with specific consideration to the nature of patient contact and intended clinical use, potential hazards associated with the materials of construction, clinical history of the materials of construction, and much more as outlined above. The biological evaluation report is prepared according to ISO 10993-1, US FDA Biocompatibility Guidance and ISO 14971. The report we prepare for you will follow a risk management framework including:

• Risk analysis including a review of raw materials data (at a minimum), manufacturing process/es and when available, non-clinical studies, clinical data and post-market surveillance data
• Risk evaluation (i.e., discussion based on gathered information to determine whether or not complementary tests are necessary)
• Risk control (i.e., testing plan, including chemical characterization and/or biological tests to mitigate identified/remaining biological risks not appropriately addressed)
• Overall risk assessment (i.e., after implementation of risk control measures, when required, to determine whether implemented measures are sufficient to mitigate risks or whether any new risks are raised and further investigations are necessary)
• Re-assessment of risk (in the case of device changes)

Experience and Peer Reviews Add Extra Measure of Certainty

NAMSA conducts 100,000+ biological safety tests and prepares hundreds biological safety plans and/or reports each year. Our team has deep expertise with a wide variety of therapeutic areas.  In addition, our team of Board-Certified Toxicologists (DABTs) are available to provide credibility as a third-party reviewer and to vigorously critique scientific claims and research to ensure integrity of data and resultant claims. NAMSA has numerous accreditations, including ISO/IEC 17025.