Post-Market Surveillance

Smithers Pira provides expert support and medical device testing for companies undertaking post-market surveillance on their medical devices and products.

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.

Our experts can provide 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, our sister company Smithers Rapra provides physical and chemical analysis of plastics and rubbers – enabling us to investigate the full spectrum of potential failure possibilities.

Accreditation

Our laboratories hold UKAS 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.

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