BSI — Certifies Management Systems & Products

BSI Healthcare is a world-class Notified Body and Registrar providing rigorous regulatory and quality management reviews and product certification for medical device manufacturers.

We contribute to our clients’ success in the global medical device industry by accelerating access to international markets. BSI has been conducting business in more than 100 countries for over 100 years. Our experienced healthcare team specializes in high-risk, invasive, combination and implantable products. We are committed to providing programs that combine speed with experience, integrity, independence and predictability.