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) Food standards > View all standards >
Access and buy standards How to access and buy > Buy standards > Standards subscriptions > BSOL > Full standards collections Compliance Navigator > 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 View all BSI services >
Consulting practices Construction safety > Cyber risk and advisory > Data management and security technologies > Digital trust > Environmental > Ergonomics > Industrial hygiene > Information solutions > Remediation program management > Safety > Security testing > Supply chain risk > Sustainability >
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 > Sustainability > - Circular economy > View all topics >
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 >
Careers > Events and webinars > Media centre/press room > Social responsibility > Modern slavery statement Contact us >
Hybrid audits for medical devices > UKCA for medical devices > In vitro diagnostics regulation > Medical device regulation > Medical devices and COVID-19 > Medical devices and Brexit >
Upcoming Webinars Clinical masterclass series > Join this series of 5 insightful webinars, to hear from our BSI experts regarding various aspects of the MDR, from post-market clinical follow-up, to helping you with your medical device software.
Medical Device services CE marking for medical devices > 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 Hybrid audits for medical devices > UKCA for medical devices > In vitro diagnostics regulation > Medical device regulation > Product lifecycle > Role of the notified body > Transfer to BSI > What is an external clinician? >
Featured training ISO 13485:2016 introduction > ISO 14971:2019 risk management > IVDD to IVDR transition > MDD to MDR 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
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 >
2019 newsletters . January > February > March > April > May > June > July > August > September > October > November > December >
