Populair ISO 9001 Kwaliteitsmanagement > ISO 13485 Medical Devices > ISO 14001 Milieumanagement > ISO 22301 Business Continuity Management > ISO/IEC 27001 Informatiebeveiliging > ISO 45001 (OHSAS 18001) G&VW-Managementsysteem > ISO 50001 Energiemanagement > Bekijk alle normen >
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Info over normen Wat zijn normen > Lees hoe normen kunnen helpen Doe mee > Ontwikkel normen, word lid van een comité en werk mee aan de normengemeenschap
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Audit, certificering en training Beoordeling en certificering > ISO-certificering en overige, bijv.: IATF, FSSC Audit en verificatie > Audits van leveranciers, specifieke audits en interne audits Testen van producten en certificering > BSI-keurmerk Kitemark, CE-markering en -verificatie, Markttoegangsoplossingen Valideren van door BSI afgegeven certificaten > Controle van bedrijfs-, locatie- en productcertificaten
Training en cursussen > Individuele, groeps- en bedrijfsbrede training Diensten voor medische hulpmiddelen > CE-marketing voor medische hulpmiddelen en in-vitrodiagnostiek, Kwaliteitsmanagement voor medische hulpmiddelen BSI Connect >
Onderwerpen - BSI voor sectorrapporten, onderzoek en nieuws Digitale bouw > BIM, 'smart cities' en aanverwante middelen Toekomst van mobiliteit > Toegang tot de mondiale markt > Gezondheid en veiligheid > Informatiebeveiliging > Cyberveiligheid, privacy (AVG) en naleving
Innovatie > Internet of things (IoT) > Organisatorische veerkracht > Kringloopeconomie en duurzaamheid > Alle onderwerpen bekijken >
Bestuur > Onze juridische informatie > Ons koninklijk handvest (Royal Charter) > Britse nationale normalisatie-instelling >
Vacatures > Evenementen en conferenties > Mediacentrum en pers > Sociale verantwoordelijkheid > verklaring omtrent moderne slavernij Contactinformatie >
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: European Regulations > 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 revision > Medical Device Regulation revision > 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 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 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 new regulations > 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 > Medical Device Software 2.1/6:2012 > 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) US Food and Drug Adminstration > 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 > MDMA (USA) Medical Device Manufacturers Association > BIVDA (UK) British In Vitro Diagnostics Association >