As an IVD Notified Body, our team of technical specialists can support you with assessment against the requirements of the IVD Directive 98/79/EC so that you can place a CE Mark on your device and access the European market.
Over 70% of the top medical device companies work with BSI, and our profound expertise enables us to build long-term relationships with our customers.
BSI employs over 120 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.
Our core competencies and unique skills are calibrated to handle our customer’s extensive portfolio of medical technologies.