Medical Device Testing
Medical devices is one of the largest growing industries in the life sciences sector today. Medical devices are extremely diverse, and require various different levels of safety or biocompatibility testing prior to market release, or upon updating of vital medical device components. These tend to fall under the ISO 10993 series of tests.
At Wickham Laboratories, our medical device testing services staff are fully versed in medical device standards, and have experience with a wide range of medical device types, along with the different methods used to test them. These methods will vary depending on factors such as level of patient contact in terms of duration, and where in the body they are likely to be used or applied. Our approach is to listen and fully understand your outsourcing requirements, then translate this information into an effective plan, to fully address your medical device testing needs.
Most of our medical device testing is conducted under GLP study, which is particularly useful where the client is seeking regulatory approval of a product. We are able to undertake development work to confirm proof of concept, as well as handle routine analysis required for sterilisation and bioburden testing. Our services meet the stringent requirements of the regulators, with our reports supporting claims for CE marking at various notified bodies and 510K submissions in the United States. We are conversant with the microbiological requirements of ISO 11135-1, 11737-1 & 2, and 10933-5, as described below:
In addition to these ISO standards, we are able to work with approved partners to sub-contract other testing depending on your requirements. For further information regarding our medical device testing capabilities, please follow the links in the sidebar or download an overview via PDF, here.