Medical Device Testing
Medical device testing is one of the most complex services offered in the life sciences sector, both for the diversity of the devices tested and for the different level of safety or biocompatibility required prior to approval for use in patients. It is also one of the fastest growing industries in healthcare with a high demand for reliable testing services.
The classification of ‘medical device’ covers a wide range of device types, and each requires various levels of safety or biocompatibility testing prior to market release and again if any of the design components and materials are updated. The required tests are generally referred to as the ISO 10993 or USP Plastic Class I-IV series, although there are a variety of other tests which may be required (such as the sterility and bioburden testing covered by the ISO 11135 and 11737 series).
In collaboration with our approved partners, we now offer a full suite of medical device testing, including the following tests:
- 10993-3: Genotoxicity
- 10993-4: Haemocompatibility
- 10993-5/USP 87: Cytotoxicity
- 10993-6: Implantation
- 10993-10/USP 88: Sensitisation, Skin Irritation and Pyrogenicity
- 10993-11/USP 88: Acute, Sub-acute and Chronic Systemic Toxicity
- 11135-1 and 11737-2: Sterility Testing
- 11737-1: Bioburden Determination
At Wickham Laboratories, our qualified technical experts and partners are fully versed in the standards governing medical device testing for development work in proof of concept projects, regulatory submission packages and routine post market authorisation analysis. We have experience with a wide range of device types, along with the different methods used to test them, which is vital given 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.
Most of our medical device testing is conducted under GLP study plans, which are particularly useful where the client is seeking regulatory approval of a product for instance via CE marking claims support with notified bodies, or a 510K submission in the United States. Our team will assess each device on an individual basis to offer the best advice for your specific requirements.
For further information regarding our medical device testing capabilities, please follow the links in the sidebar or download an overview via PDF, here.