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 > Market access solutions, CE marking and verification, BSI Kitemark 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 Digital trust > Environmental health and safety > Supply chain > Sustainability > View all consulting 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 > 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 >
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 >
To help ensure you are kept up to date with the medical devices industry, we have provided key links to useful guidance documents, professional and trade associations and regulatory websites below.
Guidance documents Download the latest regulatory guidance. European Commission MDR/IVDR Factsheet June 2019 > European Commission Medical Devices guidance and legislation > European Commission Harmonised Standards > NBOG Notified Body Operations Group Guidance > EU Regulation on Medical Devices (MDR) 2017/745 > EU Regulation on In Vitro Diagnostic Medical Devices (IVDR) 2017/746 > Directive 90/385/EEC AIMD > Directive 93/42/EEC MD > Directive 98/79/EC IVD > Medical Device Software 2.1/6:2012 > MedDev 2.7.1 Rev 4 > MHRA (UK) Guidance on Human Factors >
Regulatory links Stay up to date with regulatory changes. MHRA (UK) Medicines and Healthcare Products Regulatory Agency > VWS (NL) Ministry of Health, Welfare and Sport > IGJ (NL) Health and Youth Care Inspectorate > FDA (USA) Food and Drug Administration > NBOG Notified Body Operations Group > IMDRF International Medical Device Regulators Forum > European Commission Medical Devices >
Professional associations Keep in touch with key professional associations. RAPS (USA) Regulatory Affairs Professionals Society > ASQ (USA) Biomedical Division > FDLI (USA) The Food and Drug Law Institute > TOPRA (UK) The Organisation for Professionals in Regulatory Affairs >
Trade associations Keep in touch with key trade associations. TEAM NB (EU) The European Association for Medical devices of Notified Bodies > AdvaMed (USA) Advanced Medical Technology Association > ABHI (UK) Association of British HealthTech Industries > BIVDA (UK) British In Vitro Diagnostics Association >
Media Center Stay up to date with latest news and announcements from BSI and the medical devices industry. View the latest news >
Medical device training BSI runs online, public or in-house training courses. For training at your place of work, call us on +1 888 429 6178. View all training courses >
Events and conferences We run a variety of events and conferences from seminars, exhibitions and roadshows. View all events >
