https://medtechcyberstandards.com/ https://medtechcyberstandards.com/og-image.png MedTech Cybersecurity Standards Hub Open reference for medical-device cybersecurity standards, regulations, and guidance worldwide. https://medtechcyberstandards.com/icon-512.png MedTech Cybersecurity Standards Hub mark Site icon — shield with section mark and plus. https://medtechcyberstandards.com/standards https://medtechcyberstandards.com/og-image.png MedTech Cybersecurity Standards Hub Open reference for medical-device cybersecurity standards, regulations, and guidance worldwide. https://medtechcyberstandards.com/crosswalk https://medtechcyberstandards.com/og-image.png MedTech Cybersecurity Standards Hub Open reference for medical-device cybersecurity standards, regulations, and guidance worldwide. https://medtechcyberstandards.com/compare https://medtechcyberstandards.com/og-image.png MedTech Cybersecurity Standards Hub Open reference for medical-device cybersecurity standards, regulations, and guidance worldwide. https://medtechcyberstandards.com/timeline https://medtechcyberstandards.com/og-image.png MedTech Cybersecurity Standards Hub Open reference for medical-device cybersecurity standards, regulations, and guidance worldwide. https://medtechcyberstandards.com/journey https://medtechcyberstandards.com/og-image.png MedTech Cybersecurity Standards Hub Open reference for medical-device cybersecurity standards, regulations, and guidance worldwide. https://medtechcyberstandards.com/map https://medtechcyberstandards.com/og-image.png MedTech Cybersecurity Standards Hub Open reference for medical-device cybersecurity standards, regulations, and guidance worldwide. https://medtechcyberstandards.com/methodology https://medtechcyberstandards.com/og-image.png MedTech Cybersecurity Standards Hub Open reference for medical-device cybersecurity standards, regulations, and guidance worldwide. https://medtechcyberstandards.com/about https://medtechcyberstandards.com/og-image.png MedTech Cybersecurity Standards Hub Open reference for medical-device cybersecurity standards, regulations, and guidance worldwide. https://medtechcyberstandards.com/changelog https://medtechcyberstandards.com/og-image.png MedTech Cybersecurity Standards Hub Open reference for medical-device cybersecurity standards, regulations, and guidance worldwide. https://medtechcyberstandards.com/sponsor https://medtechcyberstandards.com/og-image.png MedTech Cybersecurity Standards Hub Open reference for medical-device cybersecurity standards, regulations, and guidance worldwide. https://medtechcyberstandards.com/guides/fda-vs-eu-mdr-cybersecurity https://medtechcyberstandards.com/og-image.png MedTech Cybersecurity Standards Hub Open reference for medical-device cybersecurity standards, regulations, and guidance worldwide. https://medtechcyberstandards.com/regions/us https://medtechcyberstandards.com/og-regions/us.jpg United States · FDA Editorial illustration representing the U.S. FDA medical device cybersecurity framework — Section 524B and SPDF. https://medtechcyberstandards.com/regions/eu https://medtechcyberstandards.com/og-regions/eu.jpg European Union Editorial illustration representing the EU MDR, NIS2, and Cyber Resilience Act framework for medical device cybersecurity. https://medtechcyberstandards.com/regions/uk https://medtechcyberstandards.com/og-regions/uk.jpg United Kingdom · MHRA Editorial illustration representing the UK MHRA framework for medical device cybersecurity. https://medtechcyberstandards.com/regions/canada https://medtechcyberstandards.com/og-regions/canada.jpg Canada · Health Canada Editorial illustration representing Health Canada pre-market cybersecurity guidance. https://medtechcyberstandards.com/regions/japan https://medtechcyberstandards.com/og-regions/japan.jpg Japan · PMDA Editorial illustration representing PMDA medical device cybersecurity guidance. https://medtechcyberstandards.com/regions/china https://medtechcyberstandards.com/og-regions/china.jpg China · NMPA Editorial illustration representing NMPA medical device cybersecurity registration framework. https://medtechcyberstandards.com/regions/australia https://medtechcyberstandards.com/og-regions/australia.jpg Australia · TGA Editorial illustration representing TGA medical device cybersecurity guidance. https://medtechcyberstandards.com/regions/international https://medtechcyberstandards.com/og-regions/international.jpg International consensus standards Editorial illustration representing IMDRF, ISO, IEC, NIST, and AAMI consensus standards. https://medtechcyberstandards.com/regions/brazil https://medtechcyberstandards.com/og-regions/brazil.jpg Brazil · ANVISA Editorial illustration representing ANVISA RDC 751 medical device cybersecurity rules. https://medtechcyberstandards.com/standards/fda-premarket-2023 https://medtechcyberstandards.com/covers/fda-premarket-2023.jpg FDA Premarket Cybersecurity Guidance (Feb 2026) FDA Premarket Cybersecurity 2026 - FDA CDRH (United States) https://medtechcyberstandards.com/standards/fda-postmarket-2016 https://medtechcyberstandards.com/covers/fda-postmarket-2016.jpg FDA Postmarket Cybersecurity Guidance FDA Postmarket Cybersecurity 2016 - FDA CDRH (United States) https://medtechcyberstandards.com/standards/fda-524b https://medtechcyberstandards.com/covers/fda-524b.jpg FD&C Act §524B (Cyber Devices) 21 USC 360n-2 (Section 524B) - U.S. Congress / FDA (United States) https://medtechcyberstandards.com/standards/fda-rta https://medtechcyberstandards.com/covers/fda-rta.jpg RTA Policy FDA RTA Policy - FDA CDRH (United States) https://medtechcyberstandards.com/standards/ntia-sbom https://medtechcyberstandards.com/covers/ntia-sbom.jpg NTIA SBOM Minimum Elements NTIA SBOM Minimum Elements - NTIA / CISA (United States) https://medtechcyberstandards.com/standards/eu-mdr https://medtechcyberstandards.com/covers/eu-mdr.jpg EU MDR 2017/745 Regulation (EU) 2017/745 - European Parliament & Council (European Union) https://medtechcyberstandards.com/standards/mdcg-2019-16 https://medtechcyberstandards.com/covers/mdcg-2019-16.jpg MDCG 2019-16 Cybersecurity Guidance MDCG 2019-16 Rev.1 - Medical Device Coordination Group (European Union) https://medtechcyberstandards.com/standards/eu-cra https://medtechcyberstandards.com/covers/eu-cra.jpg EU Cyber Resilience Act Regulation (EU) 2024/2847 - European Parliament & Council (European Union) https://medtechcyberstandards.com/standards/eu-nis2 https://medtechcyberstandards.com/covers/eu-nis2.jpg EU NIS2 Directive (EU) 2022/2555 - European Parliament & Council (European Union) https://medtechcyberstandards.com/standards/mhra-samd https://medtechcyberstandards.com/covers/mhra-samd.jpg MHRA SaMD / AIaMD Programme MHRA SaMD/AIaMD Roadmap - MHRA (United Kingdom) https://medtechcyberstandards.com/standards/hc-cyber https://medtechcyberstandards.com/covers/hc-cyber.jpg Health Canada Cybersecurity Guidance HC Premarket Cybersecurity Guidance - Health Canada (Canada) https://medtechcyberstandards.com/standards/pmda-cyber https://medtechcyberstandards.com/covers/pmda-cyber.jpg PMDA / MHLW Cybersecurity Guidance MHLW Cybersecurity Notification - PMDA / MHLW (Japan) https://medtechcyberstandards.com/standards/nmpa-cyber https://medtechcyberstandards.com/covers/nmpa-cyber.jpg NMPA Cybersecurity Registration Guideline NMPA Technical Guideline - NMPA (China) https://medtechcyberstandards.com/standards/tga-cyber https://medtechcyberstandards.com/covers/tga-cyber.jpg TGA Cybersecurity Guidance TGA Cyber Security Guidance - TGA (Australia) https://medtechcyberstandards.com/standards/anvisa-rdc-751 https://medtechcyberstandards.com/covers/anvisa-rdc-751.jpg ANVISA RDC 751/2022 ANVISA RDC 751/2022 - ANVISA (Brazil) https://medtechcyberstandards.com/standards/iec-81001-5-1 https://medtechcyberstandards.com/covers/iec-81001-5-1.jpg IEC 81001-5-1 IEC 81001-5-1:2021 - IEC / ISO (International / Consensus) https://medtechcyberstandards.com/standards/iec-62304 https://medtechcyberstandards.com/covers/iec-62304.jpg IEC 62304 IEC 62304:2006+A1:2015 - IEC (International / Consensus) https://medtechcyberstandards.com/standards/iso-14971 https://medtechcyberstandards.com/covers/iso-14971.jpg ISO 14971 ISO 14971:2019 - ISO (International / Consensus) https://medtechcyberstandards.com/standards/aami-tir57 https://medtechcyberstandards.com/covers/aami-tir57.jpg AAMI TIR57 AAMI TIR57:2016 - AAMI (International / Consensus) https://medtechcyberstandards.com/standards/imdrf-cyber-principles https://medtechcyberstandards.com/covers/imdrf-cyber-principles.jpg IMDRF Cybersecurity Principles IMDRF/CYBER WG/N60 - IMDRF (International / Consensus) https://medtechcyberstandards.com/standards/imdrf-samd https://medtechcyberstandards.com/covers/imdrf-samd.jpg IMDRF SaMD Framework IMDRF SaMD - IMDRF (International / Consensus) https://medtechcyberstandards.com/standards/iso-29147 https://medtechcyberstandards.com/covers/iso-29147.jpg ISO/IEC 29147 ISO/IEC 29147:2018 - ISO/IEC (International / Consensus) https://medtechcyberstandards.com/standards/iso-30111 https://medtechcyberstandards.com/covers/iso-30111.jpg ISO/IEC 30111 ISO/IEC 30111:2019 - ISO/IEC (International / Consensus) https://medtechcyberstandards.com/standards/nist-csf https://medtechcyberstandards.com/covers/nist-csf.jpg NIST CSF 2.0 NIST CSF 2.0 - NIST (International / Consensus)