BSI Healthcare and Testing Services

BSI offers a full range of testing and certification services from research and development, pre-production, prototype, batch and audit to full compliance testing.  BSI - a Notified Body for CE marking and owner of the prestigious Kitemark – has one of the widest testing and certification capabilities in the world.

BSI would like to correct any recent inferences in the media linking BSI Kitemark to medical devices. The Kitemark is a BSI certification mark but is not used with implantable medical devices.

Medical Devices are regulated by EU directives. Responsibility to ensure the directives are fully implemented falls to each member state and in the UK this is the Medicines and Healthcare products Regulatory Agency (MHRA). Under the auspices of the MHRA, BSI is an independent review body that conducts conformity assessments to the relevant EU Directives.