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 > Food standards > View all standards >
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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 > Food standards > View all standards >
Access and buy standards How to access and buy > Decide which option works best for your business Buy standards > Standards subscriptions > BSOL > Full standards collections Compliance Navigator > Medical device standards Eurocodes PLUS > Structural design standards BSI Membership > Services include knowledge centre, events and discounts
About standards What are standards? > Find out on how standards can help The role of BSI > UK Standards Organization, ISO, IEC, CEN, CENELEC, ETSI Get involved > Become a standards maker, join a committee Have your say > Propose or comment on a standard
Standards and information Access and buy standards > Search our standards catalogue Develop a standard > Work with BSI to develop a standard Online subscription services > BSOL, Compliance Navigator, Eurocodes PLUS, BSI Membership and SCREEN Standards services >
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
Consulting practices Cybersecurity and information resilience > Environmental health and safety > Standards and standardization > Includes technical assistance, developing private standards, research and insight to form standards strategy and policies 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 >
Blogs Built Environment > Cybersecurity and information resilience > Food Industry > Medical devices > Small Business > View all blogs >
About BSI > BSI impartiality > Our accreditation > Our clients and partners > Our financial information >
Our governance > Our legal information > Our Royal Charter > UK National Standards body > The global role of BSI as the national standards body >
Careers > Events and conferences > Media centre/press room > Social responsibility > Modern slavery statement Contact us >
CE Marking: European Regulations > ISO 13485 Quality Management > Global medical solutions > ISO 14971 Risk Management > Medical Device Single Audit Program (MDSAP) > Compliance Navigator > Training Courses > View all services >
Popular topics BSI Medical Devices and Brexit > ISO 13485 Revision > OBL / Virtual Manufacturers > Transfer to BSI > Unannounced audits > Role of a Notified Body > Product Lifecycle >
Featured training ISO 13485 Transition & Auditor Refresher > Medical Device Single Audit Program (MDSAP) >
AIMD > Active Devices > Ancillary medicinal substances > Devices utilizing animal tissue > Electronic Cigarettes > In Vitro Diagnostics > Medicinal and Biologics > Microbiology and Sterile Devices > View all technologies >
Mobile Devices > Nanomaterials > Ophthalmic Devices > Orthopaedic and Dental Devices > Software as a Medical Device > Vascular Devices > Woundcare >
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Transfer to BSI Kick start 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 >
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 accelerated 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.
