The ISO 10993 implications must be considered from the outset of medical device design, and the balance struck between device functionality and toxicity to the body. Assessment of other influencing factors such as leachables, residues and contaminants should also be considered at this stage.
Our Biocompatibility Testing:
We offer a full suite of medical device testing under ISO 10993 (including genotoxicity, haemocompatibility, and pyrogenicity), however, we most frequently perform 10993-5; in vitro Cytotoxicity Test. This test was introduced as part of our commitment to the use of alternative methods wherever possible and allows us to use a non-animal model to assess any potential detrimental effects of medical devices or their components, in a highly controlled manner.
We are proud of our extensive knowledge and experience in this field; as such, we can advise on the most appropriate methods for the testing of your medical device. If your biocompatibility testing requirements cannot be fully conducted in-house, we also work with several approved partners to provide a full range of testing methods, for the ISO 10993 series.
GLP Offerings:
For Medical devices being submitted for regulatory approval you may require GLP compliance from your biocompatibility testing. As such, we are equipped with MHRA GLP certification and maintain an up to date understanding of GLP regulations as they progress and change.
When GLP compliance is required and some of your testing cannot all be conducted in-house; our approved partners are also GLP compliant and have been audited by our quality assurance team. Studies with our approved partners are conducted as Multi-site studies to keep work compliant while not imposing extra complexity on you.
Biocompatibility Testing FAQ
Which tests will my product need?
- Contact type such as implantation versus surface devices
- Specific contact point such as intact skin versus breached skin
- Contact duration