Transfer to BSI

Transfer to BSI

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Transfer to BSI
Transfer to BSI
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We can offer a seamless service

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, and your application will be supported by a dedicated team of medical device experts.

We can offer a seamless service with comprehensive support and the absolute minimum level of disruption.

What is the CE marking transfer process?

transfer process flow chart

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.

Transferring your ISO 13485 certification

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.

Find out what our customers think >

Benefits of choosing 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 and Regulations.

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

  • Internal product experts and auditors
  • BSI Medical Devices has a team of more than 750; our technical experts have experience encompassing the full range of medical devices and management system standards
  • Full EU medical devices scope: Directives (AIMD, IVDD or MDD) and Regulations (IVDR or MDR) capability
  • Single technical point of contact
  • Responsive and robust conformity assessments

 

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