Biological evaluation of a device is a critical design consideration for manufacturers. In the earlier days, manufacturers would select the tests simply by referring to the ISO10993-1 standard and this approach was acceptable. With the publication of the new ISO10993-1 standard as well as the new US FDA guidance, the focus has shifted from conducting tests to doing a biological risk assessment. This involves research of literature, reviewing existing data, preparing a Biological Evaluation Plan and a Biological Evaluation Report.
We have in-house competency to provide services of biological risk assessment. Our team for biosafety evaluation is led by a highly qualified doctorate in toxicology with more than a decade of experience in this area.
We provide the following services in the area of biological safety evaluation:
- Prepare biological risk assessments for the evaluation of the biological safety of medical devices according to ISO 10993-1, considering the risks due to the materials of construction, clinical use, type and duration of patient contact, biocompatibility and chemical testing performed, patient population, regulatory guidance, and safety thresholds of extractable chemicals.
- Prepare toxicological risk assessments of leachable and extractable chemicals that can leach out of medical devices. This is done through toxicological literature searches, calculated tolerable intake/exposure of the chemicals, and subsequent margin of safety determinations as it relates to patient exposure in accordance with ISO 10993-17.
- Prepare gap analysis documents to ensure previously performed biocompatibility studies comply to the most recent regulatory requirements.
- Prepare evaluation plans for determining the safety of medical devices.
- Advise clients on technical issues related to biocompatibility and material characterization.
- Review plans, protocols and reports of biological testing prepared by labs, prior to their final implementation
- Prepare test strategies in co-ordination with test labs