Since 1979, BSI has supported the global Medical Device Industry through the provision of a comprehensive range of testing and certification services. BSI’s medical and laboratory devices testing specialises in safety and essential performance testing. Test programmes can be tailored to selected specifications and sub-clauses to meet the individual needs of clients.
The extensive range of testing services provided covers active and non-active devices. Types of testing include:
- Electrical safety testing
- Latex testing
BSI’s partnership approach offers manufacturers and importers the opportunity to discuss all applicable standards, directives for CE marking and product certification Kitemark with our in-house experts relating to the safety requirements for medical and laboratory devices.
BSI test reports and certificates are recognised globally as independent proof of compliance with standards and other specifications thereby meeting local regulatory requirements. Test results may form part of your Technical File required for CE marking. 510k reviews enable products to be exported to the USA.
BSI can assist manufacturers through the research and development phase of their products. Our fully equipped test laboratories can be utilised for development or full compliance testing to suit your needs.
For further information about testing for Medical Devices, please contact us.
