If you design, develop, produce, install or service any medical device, you need to comply with the requirements set out in various European and International Directives. To help manufacturers sift through the minefield of regulations, BSI can help with best practice guidelines, standards, supporting documentation and seminars. We offer essential services for medical device manufacturers, healthcare practitioners and users of healthcare information.
As the largest and leading certification body and Notified Body our knowledge is unmatched. We provide services that help manufacturers understand what they need to do to place compliant devices on markets throughout the world.
Services offered by BSI include: