How BSI can help your medical device business

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


Our commitment to excellence

Medical device servicesManufacturers 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.


Supporting you with the latest regulatory changes

To support you through your product development journey and to keep you  up to date with the latest regulatory changes, we have dedicated webpages that focus on the latest regulatory changes such as understanding the process of unannounced audits and learning more about the practicalities of the revision to ISO 13485 QMS.

Below you will find links where you can learn more about these changes.