Popular Quality management > ISO 9001 Quality management for medical devices > ISO 13485 Business continuity > ISO 22301 Information security > ISO/IEC 27001 View all standards >
Access and buy standards How to access and buy > Buy standards > Standards subscriptions > BSOL > Full standards collections Compliance Navigatior > Medical device standards
Auditing, certification and training Assessment, ISO certification and others: IATF, FSSC... > Auditing and verification > Product testing and certification > BSI Kitemark, CE marking and verification, Market access solutions Validate BSI-issued certificates >
Training courses > Medical devices services > BSI Connect > Software tools and solutions for audit, risk, compliance and supply chain management
Industry reports, research and news Digital construction > BIM, smart cities and connected assets Future of mobility > Global market access > Health, safety and well-being > Information security > Cybersecurity, privacy (GDPR) and compliance
Innovation > Internet of things (IoT) > Organizational resilience > Sustainability > - Circular economy > View all topics >
About BSI > BSI impartiality > Our accreditation > Our clients and partners > Our financial information >
Our legal information > Our purpose, mission and vision > Our Royal Charter > UK National Standards body > The global role of BSI as the national standards body >
Careers > Events and webinars > Media centre/press room > Sustainability > Modern slavery statement Contact us >
Are you an SME? > EUDAMED for medical devices > AI for medical devices > Hybrid audits for medical devices > UKCA for medical devices > In vitro diagnostics regulation > Medical device regulation >
Clinical masterclass toolkit > Medical devices and COVID-19 > Medical devices and Brexit > Role of a Notified Body > Product Lifecycle >
Medical Device services CE marking > Compliance navigator > Drug-device combination products > ISO 13485 quality management > Medical device single audit program > Medical electrical equipment and systems > View all services >
Popular topics EUDAMED for medical devices > AI for medical devices > Hybrid audits for medical devices > UKCA for medical devices > In vitro diagnostics regulation > Medical device regulation > What is an external clinician? > Product lifecycle > Transfer to BSI >
Featured training ISO 13485:2016 introduction > ISO 14971:2019 risk management > IVDD to IVDR transition > MDSAP fundamentals and readiness > View all training >
Market access Brazil > Canada > Europe > Japan > Hong Kong > Malaysia > Taiwan > United Kingdom > United States > View all market access >
Software as a medical device > Vascular devices > Article 16(4) Certification (MDR & IVDR) > View all technologies >
