CE-Excellence Let our experts support your global market access with robust, efficient reviews under our focused CE Marking technical documentation reviews. Find out more about CE Marking with BSI
Transfer to BSI Kickstart your journey of ongoing business development and growth by seamlessly transferring ISO 13485, CE Marking, CMDCAS or CLASS III Design Dossier Certificates to BSI Transfer to BSI
ISO 13485 Quality Management The world’s most popular standard for medical devices quality management has been revised for the first time since 2003. Find out more
We have proven worldwide expertise ensuring clients meet the essential requirements for a given geography and we provide comprehensive solutions covering the full spectrum of regulatory requirements. Globally we run a variety of events and conferences including training courses to help you gain a deeper understanding of existing standards so you can embed them into your business to enhance performance, manage risk and improve sustainability.
Why choose BSI as your notified body? Product expertise – our diverse and experienced team brings in-depth knowledge and understanding of complex medical device technologies. Global access – we operate in over 180 countries with more than 100 years of experience and offices around the world to serve you. Timely market access – providing flexible solutions for manufacturers needing efficient pathways to global markets. Confidence – our stringent review process combines speed with experience, integrity, independence and predictability. Experience – our team has over 1750 years’ combined industry and regulatory experience, so we understand the challenges you face.