Popular ISO 9001 Quality management > ISO 13485 Quality management for medical devices > ISO 14001 Environmental management > ISO 22301 Business continuity > ISO/IEC 27001 Information security > ISO 45001 (OHSAS 18001) Occupational health and safety > View all standards >
Access and buy standards How to access and buy > Decide which option works best for your business Buy standards > Standards subscriptions (UK website) > BSOL > Full standards collections Compliance Navigatior > Medical device standards
About standards What are standards? > Find out how standards can help Have your say > Consumer alerts >
Standards and information Access and buy standards > Search our standards catalogue Develop a standard (UK website) > Work with BSI to develop a standard Online subscription services (UK website) > BSOL, Compliance Navigator, Eurocodes PLUS, BSI Membership and SCREEN Standards services (UK website) >
Auditing, certification and training Assessment and ISO certification > ISO certification and others eg: IATF, FSSC Auditing and verification > Supplier audits, custom audits and internal audits Product testing and certification > BSI Kitemark, CE marking and verification, Market access solutions Validate BSI-issued certificates > Check company, site and product certificates
Training courses > Individual, group and company-wide training Medical devices services > CE marking for medical devices, MDR and IVDR, quality management for medical devices Compliance software and solutions > Software tools and solutions for governance, cyber security, risk and supply chain management BSI Certification Guidebooks >
Consulting practices Cybersecurity and information resilience > Supply chain management > View all BSI services >
Industry reports, research and news Digital construction > BIM, smart cities and connected assets Future of mobility > Global market access > Health, safety and wellbeing > Information security > Cybersecurity, privacy (GDPR) and compliance
Innovation > Internet of things (IoT) > Organizational resilience > Sustainability and circular economy > View all topics >
About BSI > BSI impartiality > Our accreditation > Our clients and partners > Our financial information >
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, MDSAP 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.