BSI

BSI Healthcare contributes to our clients’ success in the global medical device industry by accelerating access to international markets. We are a world-class Notified Body dedicated to providing rigorous regulatory and quality management reviews and product certifications for medical device manufacturers. 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. BSI services include CE Marking, ISO 13485, CMDCAS, Japan PAL, FDA Third-Party Programs, Standards and Training. We are committed to providing programs that combine speed with experience, integrity, independence and predictability.