BSI Medical Devices
BSI Medical Devices offers certification services to place safe and compliant medical devices on the market: as independent market-leading experts in patient safety, we enable effective market access for medical technologies.
We are:
- Full scope Notified Body (2797) MDR & IVDR.
- Full scope UK Approved Body (0086) UKCA.
- Accredited ISO 13485 Certification Body.
- Recognized Auditing Organization under the MDSAP.
- Conformity Assessment Body and registered Certification Body in many global markets.
Medical Devices & IVDs capacity and lead times applications and conformity assessments are regularly published on our website.
We conduct impartial, responsive, robust and thorough conformity assessments, evaluations and certifications that are recognized and trusted worldwide.
Please find whitepapers & guides via the links below.
Contact person
Magnus Olla
Senior Business Development Manager, Medical Devices & IVD - Nordics
M: +46 (0) 766 33 41 71
www.linkedin.com/showcase/bsi-medical-devices/
Overview
Regulatory Services – Medical Devices
Capacity & lead times MDR & IVD
A Roadmap for SMEs and Startups
Clinical
Best Practise Submission of Clinical Evaluation
Specific
MDR Annex XVI Devices without an intended medical purpose
MDR Article 117 For combination products and substance-based devices