Biological Safety of Medical Device

 
Biological safety of a medical device is an essential requirement for the market approval. New devices or pre-existing devices must undergo biological evaluation within the risk management process. Numerous international and national standards and guidance documents provide guidelines for the biological evaluation of medical devices. We help you to develop the biological safety evaluation plan of your device and organize biocompatibility testing that meets the regulatory requirement of different markets. 

To achieve this, we offer:

  • Help to categorize your device based on nature and duration of body contact

  • Perform material characterization by assessment of materials of construction and risk associated with it

  • Provide support in material selection

  • Review of manufacturing processes

  • Evaluation of existing data from literature research, similar/predicate devices, clinical data, animal data, etc

  • Identification of biological end points based on the gap and risk assessment

  • Organization of biological and chemical testing to evaluate the biological risk

  • Writing of Biological Evaluation Report according to the state-of-the-art ISO 10993-1, FDA Guidance Document and ISO 14971