Medical Device Biocompatibility Testing
Biocompatibility testing determines if your product is safe for contact with, or implantation into, the body, as necessary for regulatory approval. It is also an important part of medical device testing for regulatory pathways and agencies (e.g. FDA, 510k, PMDA, etc.).
It is required in order to understand if devices can have an adverse effect on biological systems. Chemical characterization is key to understanding device materials, manufacturing processes, residual sterilization compounds and any other matter that might come into contact with patients through the device.
At Lucideon we have extensive experience in biocompatibility testing and developing and validating methods for your products. We perform a wide range of in-vitro chemical testing and analysis, enabling us to prove processes and products are safe for in-vivo trials according to standards, and identify the cause of any contamination if present. We test to ISO 10993 – an essential requirement for regulatory submission.
- Extractables and Leachables method development and testing
- Chemical, physical, morphological and topographical characterization of materials
- Identification and quantification of degradation products (polymers, metals, ceramics) including sample preparation
- Ethylene Oxide sterilization - residuals testing
- Cytotoxicity testing
- Benchmark analysis of your product vs. a predicate – important to avoid doing unnecessary in vivo trials
We are official partners with Bibra, the toxicology advice and consultancy experts. Our partnership means you get a complete service offering, spanning the expertise of Lucideon and Bibra, with the convenience and visibility of just one program.
With our collaboration we can also provide toxicology hazard and risk assessments,
We analyse and interpret the in-depth data that we produce to offer you a full support service in all of your testing with us.
Should post-market failures occur, caused by biocompatibility issues, we can help to solve those failures quickly and effectively through our troubleshooting team and biocompatibility experts.
Animal testing is not offered in our portfolio of biocompatibility services.