BSI (British Standards Institution)
Your Full Scope Notified Body for MDR & IVDR
BSI (British Standards Institution) is driving regulatory excellence, to uphold the quality, safety and performance of medical devices. Helping you transfer your certification projects with confidence, clarity and continuity
BSI Medical Devices offers certification services to place safe and compliant medical devices on the market. We are:
- A leading full scope Notified Body (2797) for MDR & IVDR
- An accredited ISO 13485 Certification Body
- A recognized Auditing Organization under the Medical Device Single Audit Program (MDSAP)
- A Conformity Assessment Body and a registered Certification Body in many global markets
- Transparent MDR and IVDR application capacity and lead times
- A leading full scope UK Approved Body (0086)
BSI supports medical device and IVD manufacturers throughout their regulatory journey, from market access planning and documentation submission to certification and post-market compliance. A comprehensive collection of brochures, guides and white papers is available for free download via the BSI Toolkits page, providing practical guidance on MDR, IVDR, ISO 13485, MDSAP, clinical evaluation, UKCA, and much more: Download your free literature from the BSI toolkit here >>
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