Popular Quality management > ISO 9001 Quality management for medical devices > ISO 13485 Environmental management > ISO 14001 Business continuity > ISO 22301 Information security > ISO/IEC 27001 Occupational health and safety > ISO 45001 (OHSAS 18001) View all standards >
Access and buy standards How to access standards > Buy standards > Standards subscriptions > BSI Knowledge > Full standards collections Compliance Navigator > Medical device standards Eurocodes PLUS > Structural design standards BSI Membership > Knowledge centre, events and discounts
About standards What are standards? > How they enable better business 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 Consumer alerts > Know which products have been recalled
Working with standards Business and industry > Government > Education > Supporting students, research programmes, and young professionals Consumers and standards > Making consumers’ lives safer, fairer and better
Standards and information Access and buy standards > Develop a standard > Online subscription services > BSI Knowledge, Compliance Navigator, Eurocodes PLUS, BSI Membership Knowledge services > Shaping strategies, creating new standards and frameworks, research and insights and consultancy advisory services
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
Consulting practices Digital trust > Standards consulting > Our consultants can shape your strategies for standardization and business improvement Supply chain management > View all BSI services >
Industry reports, research and news COVID-19 > 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 > Prioritizing people > Sustainability > - Circular economy > - Net zero > View all topics >
Blogs Built environment > Digital trust > Food industry > Healthcare > 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 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 > Sustainability > Modern slavery statement Contact us >
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 >
AIMD > Active devices > Ancillary medicinal substances > Devices utilizing animal tissue > Drug-device combination products >
Electronic cigarettes > General devices > In vitro diagnostics > Medicinal and biologics > Microbiology and sterile devices >
You can stay up to date with the latest news and announcements for medical devices through our regular monthly newsletter. If you have missed any of our newsletters you can download these below in pdf format. Sign up to newsletter
2022 newsletters . January > February > March > April > May > June > July / Aug > September > October > November > December >
2021 newsletters . January > February > March > April > May > June > July > August > September > October > November > December >
2020 newsletters . January > February > March > April > May > June > July > August > September > October > November > December >
