In order to comply with the European Union Medical Device Directives, medical device manufacturers are required to conduct post-market surveillance (PMS) as part of an ongoing quality assurance process. Post-market surveillance is a critical part of a risk reduction process for medical device manufacturers, and can also enable product improvements which may have otherwise been overlooked.
Support at every stage of your PMS process
- Risk assessment: we can make an assessment of the risk associated with the device, based on numerous factors such as product status (new/revised) and intended use
- Device testing: our comprehensive testing facilities enable us to provide a range of device testing services across numerous medical devices – including syringes, aerosols and auto injectors
Reactive Post-Market Surveillance
In cases where a product has not performed as expected, our experts can undertake a failure analysis of the device to identify the root cause of the failure. Alongside our device testing capabilities we also provide physical and chemical analysis of plastics and rubbers – enabling us to investigate the full spectrum of potential failure possibilities.
Quality and Accreditation
Our laboratories hold ISO 17025 accreditation for a range of specific tests related to Packaging and Product Testing, and we can undertake work to meet GMP compliance if required.