CE-Excellence

Let our experts support your global market access with robust, efficient reviews under our focused CE Marking technical documentation reviews.

Learn more about CE Marking with BSI

Transfer to BSI

Kickstart your journey of ongoing business development and growth by seamlessly transferring ISO 13485, CE Marking, CMDCAS or CLASS III Design Dossier Certificates to BSI

Transfer to BSI

ISO 13485 Quality Management

The world’s most popular standard for medical devices quality management has been revised for the first time since 2003. 

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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:

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.
  • Timely market access – 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.