Global market access for US medical device manufacturers

BSI is the world’s first national standards body partnering with medical device manufacturers to provide impartial third-party standards based assurance, compliance, information solutions, and training. Backed by 80,000 client locations in over 100 countries, and more than 50 BSI offices, we are the trusted partner of Industry and Government professionals all over the world.

By working with BSI America, medical device manufacturers are choosing to seamlessly access global in-house experts with regulatory experience in a wide-range of product and technical areas. Our experts have extensive hands-on experience in all aspects of the product life cycle including research and development, manufacturing and quality assurance.

Helping US medical device manufacturers gain access to global markets

BSI America is an approved "full scope" Notified Body, recognized by the European Commission for 17 directives and by the FDA, CMDCAS, JPAL, LG/ZLS, and TGA. Every day, we work with our customers to deliver on our global mission: To ensure patient safety while supporting timely access to medical device technology.

We can help you gain access to new markets, select a country below to learn more:

Why choose BSI as your notified body?

  • Product expertise – our diverse and experienced team brings in-depth knowledge and understanding of complex medical device technologies.
  • Global access – we operate in over 150 countries with more than 100 years of experience and offices around the world to serve you.
  • Speed-to-market – providing flexible solutions for manufacturers needing accelerated pathways to global markets.
  • Confidence – our stringent review process combines speed with experience, integrity, independence and predictability.
  • Partnership – we focus on establishing a partnership with each client so we can work together to meet their goals.