인기 품질경영시스템 > ISO 9001 의료 기기 > ISO 13485 환경경영시스템 > ISO 14001 비즈니스연속성경영시스템 > ISO 22301 정보보호경영시스템 > ISO/IEC 27001 산업 보건 및 안전 > ISO 45001 (OHSAS 18001)
컴플라이언스경영시스템 > ISO 37301 차량용 사이버보안 > ISO/SAE 21434 자동차 정보보안 > TISAX 탄소중립 > PAS 2060 의료기기 > ISO 13485 모든 표준보기 >
표준 소개 표준이란 무엇인가 > 표준이 어떻게 도움이 될 수 있는지 알아보세요 BSI의 역할 > 영국 국가표준기구, ISO, IEC, CEN, CENELEC, ETSI 참여하기 > 표준의 제작자가 되고, 위원회에 참여하여 표준 커뮤니티에 참여하세요. 의견 말하기 > 표준을 제안하거나 의견 말하기
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산업 보고서, 리서치, 블로그, 새 소식을 위한 BSI 홈 디지털 건설 > BIM, 스마트 도시, 연결된 자산 글로벌 시장 액세스 > 이동성의 미래 > 건강 및 안전 > 정보 보안 >
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 >
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 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 > MDMA (USA) Medical Device Manufacturers Association > BIVDA (UK) British In Vitro Diagnostics Association >