1. Your initial application

2. Pre-transfer initial documentation review

3. Pre-transfer Technical Documentation and QMS review, as needed:
    • Onsite QMS review
    • MDR/IVDR/UK Regulation Technical Documentation review

4. Recommendation for acceptance of transfer:
    • Certification Panel review
    • Contact previous Notified Body/Approved Body
    • Labelling transition

5. Transfer completion

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.

1. Pre-Certification Gap Analysis (optional)
2. Pre-Transfer Review
3. Certification Review
4. Certification decision
5. Certificate awarded
6. Continuous Audit Visit cycle resumes

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.

24 of the world’s top 25 global medical device manufacturers choose BSI as their Notified Body and UK Approved Body to provide CE and UKCA marking certification under EU and UK legislation.

In addition to a wide range of supporting resources to help you navigating the highly regulated MedTech sector, we offer:

• Internal product experts and auditors
• A team of over 1000 people and technical experts specialized in encompassing the full range of medical devices and regulatory certification services
• Full-scope Notified Body and Approved Body providing conformity assessments under the applicable European and UK legislation
• Single technical point of contact
• Trusted and robust product reviews