World-renowned service for US medical device manufacturers

BSI is a leading business services provider for organizations worldwide, offering a range of services in management system certification such as ISO 13485, product testing and certification, and standardization. Our service philosophy is focused on robust and timely reviews, making us a trusted industry regulator.

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.

Globally we run a variety of events and conferences including training courses to help you gain a deeper understanding of existing standards so you can embed them into your business to enhance performance, manage risk and improve sustainability.

Popular services we offer our clients include:

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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 180 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.
  • Experience - our team has over 1750 years’ combined industry and regulatory experience, so we understand the challenges you face.