BSI employs over 130 medical device experts with experience in all aspects of the product lifecycle including research and development, manufacturing, and quality assurance. We offer specialized in-house expertise in areas ranging from sterilization processes, and animal tissue utilization to combination medical device products.
A product may be within the scope of one or more EU Medical Device Directives, and the manufacturer can usually choose different conformity assessment procedures. Some of them require a Notified Body to be involved.
Our core competencies and unique skills are calibrated to handle our customer’s extensive portfolio of medical technologies which include: