The biocompatibility of a medical device depends on several factors; chemical and physical nature of its component materials, the type of patient tissue that will be exposed to the device and duration of the exposure. Companies need to consider all the above mentioned factors while strategizing for biocompatibility testing. In addition, companies must conduct necessary testing to show that the device is safe. All devices do come with a certain amount of risk, but the goal of device designers is to minimize the risk while maximizing the benefit to patients.
Different geographies follow biocompatibility regulations that are specific to their country. The device designers and manufacturers shall comply with geography specific biocompatibility regulatory requirements. For example:
- ISO 10993 series for Europe, China, Korea, Australia and other geographies
- G95-1 Memorandum for FDA
- PFSB/ELD/OMDE Notification No. 0301-20 (March 1, 2012): Basic concepts for evaluating biological safety of medical devices required for application of manufacturing/marketing approval for Japan, MHLW/PMDA
We provide the following consulting services:
Develop test strategy
- We will work with your company to develop strategy for biocompatibility testing.
- Testing for FDA
- Testing for Europe / CE mark
- Testing for Japan etc.
Coordinate and conduct testing
- We will source and manage the contract research laboratories and coordinate testing.
- We will help your company with the sample preparations and also mitigate any unforeseen failure of tests and other issues
Test plans and reports
- We will prepare test plans and reports as well as conduct technical evaluation of the data
Biological Safety expert reviews
- We will prepare biological safety expert reviews for the products and address gaps if any
Toxicological assessment reviews
- We will prepare expert toxicological assessment reviews
Evaluation of chemical residuals (cleaning)
- We will qualify and validate the cleaning procedures for components.
- Also the toxicological safety of cleaning chemical residuals will be conducted
Evaluation of chemical residuals (storage)
- For medical devices stored in chemicals, the amount of residual chemicals remaining in the device shall be demonstrated to be toxicologically safe.
- We will work with your company determine the amount of chemicals remaining in the device and its safety
Manage ethylene oxide (Eto) residual testing
- We will strategize, source and manage contract labs, coordinate and conduct testing
Gap analysis for legacy products
- We will perform gap analysis for compliance to current biocompatibility / toxicology standards.
- Provide strategies to demonstrated compliance