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 > Artificial intelligence >
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 >
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 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 > 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 > 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 >
Talk to our experts If you’d like to know more about one of our products or services, fill out the form below and a member of our team will be in touch. Alternatively, you can email us at MedicalDevices@bsigroup.com Personal information First name* Last name* Job title* Email address* Contact number* Company details Company name* Country/region* United Kingdom Afghanistan Albania Algeria American Samoa Andorra Angola Anguilla Antarctica Antigua and Barbuda Argentina Armenia Aruba Australia Austria Azerbaijan Bahamas Bahrain Bangladesh Barbados Belarus Belgium Belize Benin Bermuda Bhutan Bolivia Bosnia and Herzegovina Botswana Brazil British Indian Ocean Territory British Virgin Islands Brunei Bulgaria Burkina Faso Burundi Cambodia Canada Cameroon Cape Verde Cayman Islands Central African Republic Chad Chile China Christmas Island Cocos (Keeling) Islands Colombia Comoros Congo (Kinshasa) Democratic Republic of the Congo Cook Islands Costa Rica Croatia Cuba Curaçao Cyprus Czech Republic Côte d’Ivoire Denmark Djibouti Dominica Dominican Republic Ecuador Egypt El Salvador Equatorial Guinea Eritrea Estonia Ethiopia Falkland Islands Faroe Islands Fiji Finland France French Guiana French Polynesia French Southern Territories Gabon Gambia Georgia Germany Ghana Gibraltar Greece Greenland Grenada Guadeloupe Guam Guatemala Guernsey Guinea Guinea-Bissau Guyana Haiti Honduras Hong Kong Hungary Iceland India Indonesia Iran Iraq Ireland Isle of Man Israel Italy Jamaica Japan Jersey Jordan Kazakhstan Kenya Kiribati Kuwait Kyrgyzstan Korea Laos Latvia Lebanon Lesotho Liberia Libya Liechtenstein Lithuania Luxembourg Macao S.A.R. Macedonia Madagascar Malawi Malaysia Maldives Mali Malta Marshall Islands Martinique Mauritania Mauritius Mayotte Mexico Micronesia Moldova Monaco Mongolia Montenegro Montserrat Morocco Mozambique Myanmar Namibia Nauru Nepal Netherlands New Caledonia New Zealand Nicaragua Niger Nigeria Niue Norfolk Island Northern Mariana Islands Norway Oman Pakistan Palau Palestinian Territory Panama Papua New Guinea Paraguay Peru Philippines Pitcairn Poland Portugal Puerto Rico Qatar Romania Russia Rwanda Réunion Saint Barthélemy Saint Helena Saint Kitts and Nevis Saint Lucia Saint Pierre and Miquelon Saint Vincent and the Grenadines Samoa San Marino Sao Tome and Principe Saudi Arabia Senegal Serbia Seychelles Sierra Leone Singapore Slovakia Slovenia Solomon Islands Somalia South Africa South Sudan Spain Sri Lanka Sudan Suriname Svalbard and Jan Mayen Swaziland Sweden Switzerland Syria Taiwan Tajikistan Tanzania Thailand Timor-Leste Togo Tokelau Tonga Trinidad and Tobago Tunisia Turkey Turkmenistan Turks and Caicos Islands Tuvalu U.S. Virgin Islands Uganda Ukraine United Arab Emirates United States of America United States Minor Outlying Islands Uruguay Uzbekistan Vanuatu Vatican Venezuela Viet Nam Wallis and Futuna Western Sahara Yemen Zambia Zimbabwe Postcode* How can we help you? I am interested in Which services are you interested in? (Select all that apply) CE (MDR) CE (Article 117) CE (IVDR) UKCA ISO 13485 MDSAP Compliance Navigator Training Artificial Intelligence Additional comments or questions Marketing preferences BSI takes your privacy seriously. From time to time we would like to contact you with details of products and/or services we offer. If you wish for BSI to contact you for marketing purposes please select which methods of contact you would like us to contact you on? (Select all that apply) Email Phone SMS Direct mail Please read the BSI Privacy Notice for further information regarding your rights. I have read the BSI Privacy Notice and consent to the processing of my personal data*
