Global market access

We are a global organization, trusted and recognized around the world with 84 offices in 31 countries. BSI The Netherlands (2797) is a leading Notified Body; we review medical devices to ensure that they conform to the requirements of the European Directives and Regulations. BSI UK (0086) is a UK Approved Body able to provide conformity assessments under the new UKCA scheme.

We hold recognition by SCC (CMDCAS, Canada), MHLW (PMD Act, Japan), Taiwan FDA (TCP program), Malaysian MoH (as a Malaysian CAB), and ANVISA (INMETRO, Brazil). We are also recognized as an MDSAP Auditing Organization.

We offer a portfolio of products and services for each stage of your certification journey, and we are committed to establishing long-term, proactive relationships with our customers.

The benefits of having experienced, professional and well qualified technical specialists cannot be overstated in the complex and ever-changing medical device industry.

BSI Medical Devices has a team of over 750 colleagues; within that team are our technical experts with experience encompassing the full range of medical devices and management system standards.

Clients work with us because we understand the challenges medical device manufacturers face in bringing compliant products to market efficiently and safely. We offer a range of flexible product review services providing you with efficient pathways to bring your product to market.

Our core competencies and unique skills are calibrated to handle our customer’s extensive portfolio of medical technologies.