Medical Device Testing Laboratories
Medical device testing is organised around a documented evaluation plan covering biological safety, sterility, packaging, performance and electrical safety appropriate to the device.
When is it used?
- Regulatory submissions and design verification
- Material or sterilisation changes
- Complaint and post-market investigations
Sample and project requirements
- Provide final, finished, sterilised devices where the standard expects them.
- State intended use, contact type and duration.