EU Referendum Result (BREXIT)

After Britain voted to leave the EU, BSI will continue to operate as an EU Notified Body.

Read our full statement to understand more about BSI's position.

BSI to open a Notified Body in the Netherlands

BSI America can help your medical device organization

We understand the specific challenges facing US medical device manufacturers and the importance of bringing innovative yet safe products to American and global markets. Ensuring the predictability and transparency of regulatory product clearance is key to maintaining a competitive edge.

Turning our experience into your expertise

Manufacturers tell us they need to work with a highly competent, customer focused Notified Body that understands the specifics of their environment and the importance of complete confidentiality around patent pending new technology.

Our services are designed to align with the steps individual clients need to take to understand what is best practice, how to achieve it and ensure that it remains an ongoing habit.

We provide rigorous quality management reviews and product certifications for medical device manufacturers around the world, and we can do it for you too.

BSI America's mission

Our mission is to ensure patient safety while supporting timely access to global medical device technology. We strive to set the global standard in thorough, responsive, predictable conformity assessments, evaluations, and certifications.

Giving you access to global markets

We have proven worldwide expertise ensuring clients meet the essential requirements for a given geography and we provide comprehensive solutions covering the full spectrum of regulatory requirements.

Specialist product experts

Our team of medical device product experts have in excess of 700 years’ experience in design and development. Recruited from industry, clinical research and academia they have designed and developed similar devices to those they are evaluating.