At BSI, we understand that having confidence in your Notified Body to deliver an efficient and robust CE marking  and Quality Management System assessment process is important. Our approach focuses on open communication from the very beginning. Your application will be supported by a dedicated team of medical device experts.

Transferring your ISO 13485 certification

If you are transferring your ISO 13485 certification to BSI, we will conduct a Pre-Transfer Review to assess your organization, current certification and compliance.

 

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Hear what our customers have to say about us

We work with a range of companies, from start-ups to multinationals, from those with novel devices to those with many years' experience, from low risk to high risk, and we have the specific expertise to support you.

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Benefits of choosing with BSI

24 of the world’s top 25 global medical device manufacturers choose BSI as their Notified Body for CE marking certification against the EU Directives.

Just some of the reasons why manufacturers are getting a better experience:

  • Internal product experts and auditors
  • Over 2,050 years of technical expertise
  • Full EU medical devices scope: MDD, AIMD, IVDD capability
  • Single technical point of contact
  • Reliability and predictability