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
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.
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.
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.
Making excellence a habit