TheArtOfService
Cross-Framework Mapping

IEC 62304:2015 Medical Device Software Lifecycle ProcessesvsNIST SP 800-82 Rev 3 — Guide to OT Security

See exactly how IEC 62304:2015 Medical Device Software Lifecycle Processes controls map to NIST SP 800-82 Rev 3 — Guide to OT Security. Pre-computed mappings, identified gaps, and coverage analysis.

17
Controls Mapped
13
Gaps Found
27%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

IEC 62304:2015 Medical Device Software Lifecycle Processes maps to NIST SP 800-82 Rev 3 — Guide to OT Security with 27% coverage across 8 directly mapped controls. Analysis of 30 IEC 62304:2015 Medical Device Software Lifecycle Processes controls identifies 22 compliance gaps — primarily concentrated in Clause 9 — Software Problem Resolution Process.

Source: TheArtOfService Knowledge Graph | 30 controls analysed | 693 frameworks | 819K+ cross-framework mappings

Control Mappings

Showing 17 of 17 mapped controls across 5 domains. Sign up to explore all 819K+ mappings across 693 frameworks.

Clause 4 — General Requirements(3 mappings)

IEC62304-4.1Quality Management System3 targets
→NIST82-CTL-05OT Configuration Management
→NIST82-RM-01OT-Specific Risk Management Framework
→NIST82-RM-05OT Security Training and Awareness

Clause 5 — Software Development Process(7 mappings)

IEC62304-5.1Software Development Planning3 targets
→NIST82-CTL-05OT Configuration Management
→NIST82-RM-01OT-Specific Risk Management Framework
→NIST82-RM-05OT Security Training and Awareness
IEC62304-5.2Software Requirements Analysis2 targets
→NIST82-IR-03OT Incident Containment
→NIST82-RM-02OT Security Program Management
IEC62304-5.3Software Architectural Design2 targets
→NIST82-IR-03OT Incident Containment
→NIST82-RM-02OT Security Program Management

Clause 7 — Software Risk Management Process(3 mappings)

IEC62304-7.2Risk Control Measures2 targets
→NIST82-IR-03OT Incident Containment
→NIST82-RM-02OT Security Program Management
IEC62304-7.4Risk Management of Software Changes
→NIST82-RM-01OT-Specific Risk Management Framework

Clause 8 — Software Configuration Management Process(2 mappings)

IEC62304-8.2Change Control2 targets
→NIST82-CTL-03OT Audit and Monitoring
→NIST82-CTL-05OT Configuration Management

Clause 9 — Software Problem Resolution Process(2 mappings)

IEC62304-9.4Use Change Control Process2 targets
→NIST82-CTL-03OT Audit and Monitoring
→NIST82-CTL-05OT Configuration Management

Related Comparisons

Other IEC 62304:2015 Medical Device Software Lifecycle Processes comparisons

IEC 62304:2015 Medical Device Software Lifecycle Processes vs TISAX — Trusted Information Security Assessment Exchange9 mappingsIEC 62304:2015 Medical Device Software Lifecycle Processes vs ICH Q10 — Pharmaceutical Quality System9 mappingsIEC 62304:2015 Medical Device Software Lifecycle Processes vs EIOPA Guidelines on ICT Security and Governance (2023)8 mappingsIEC 62304:2015 Medical Device Software Lifecycle Processes vs EBA Guidelines on ICT and Security Risk Management (EBA/GL/2024/07)8 mappingsIEC 62304:2015 Medical Device Software Lifecycle Processes vs EU GMP Annex 11: Computerised Systems8 mappingsIEC 62304:2015 Medical Device Software Lifecycle Processes vs EDM Council DCAM — Data Management Capability Assessment Model8 mappingsIEC 62304:2015 Medical Device Software Lifecycle Processes vs SSAE 18 — Attestation Standards (SOC Reporting)8 mappingsIEC 62304:2015 Medical Device Software Lifecycle Processes vs PAS 1192-5:2015 — Security-Minded Approach to BIM and Digital Built Environments8 mappings

Other NIST SP 800-82 Rev 3 — Guide to OT Security comparisons

TISAX — Trusted Information Security Assessment Exchange vs NIST SP 800-82 Rev 3 — Guide to OT Security17 mappingsASD Information Security Manual (ISM) vs NIST SP 800-82 Rev 3 — Guide to OT Security17 mappingsCISA ICS-CERT Advisories and Industrial Control Systems Security Guidelines vs NIST SP 800-82 Rev 3 — Guide to OT Security17 mappingsNIST Cybersecurity Framework 2.0 vs NIST SP 800-82 Rev 3 — Guide to OT Security16 mappingsAPI 1164 vs NIST SP 800-82 Rev 3 — Guide to OT Security16 mappingsIEC 62443 vs NIST SP 800-82 Rev 3 — Guide to OT Security16 mappingsDO-326A / ED-202A vs NIST SP 800-82 Rev 3 — Guide to OT Security16 mappingsCSA CCM v4 vs NIST SP 800-82 Rev 3 — Guide to OT Security16 mappings

Stop Paying Consultants to Read Spreadsheets

AI-powered compliance intelligence across 693 frameworks — at a fraction of consulting costs.

$0/forever

Free

  • ✓ 693 framework browser
  • ✓ Cross-framework mappings (819K+)
  • ✓ 824 compliance assessments
  • ✓ 3 AI queries & searches per day
Get Started Free
Recommended
$49/month

Professional

  • ✓ Unlimited AI Compliance Advisory
  • ✓ Unlimited full-text search
  • ✓ Framework self-assessment
  • ✓ PDF, Excel & CSV exports
Start 7-Day Free Trial →

Popular framework comparisons

NIST CSF vs NIST 800-53ISO 27001 vs NIST CSFCMMC vs NIST 800-53FedRAMP vs NIST 800-53NIST CSF vs SOC 2HIPAA vs NIST 800-53ISO 27001 vs SOC 2ISO 27001 vs ISO 27701

What are the key differences between IEC 62304:2015 Medical Device Software Lifecycle Processes and NIST SP 800-82 Rev 3 — Guide to OT Security?

IEC 62304:2015 Medical Device Software Lifecycle Processes has 30 controls across its framework, while NIST SP 800-82 Rev 3 — Guide to OT Security covers 21 controls. Direct mapping analysis identifies 8 overlapping controls (27% coverage). The frameworks diverge most significantly in Clause 9 — Software Problem Resolution Process, where 7 IEC 62304:2015 Medical Device Software Lifecycle Processes controls have no direct NIST SP 800-82 Rev 3 — Guide to OT Security equivalent.

How many controls map between IEC 62304:2015 Medical Device Software Lifecycle Processes and NIST SP 800-82 Rev 3 — Guide to OT Security?

Of 30 total IEC 62304:2015 Medical Device Software Lifecycle Processes controls, 8 map directly to NIST SP 800-82 Rev 3 — Guide to OT Security controls — representing 27% coverage. The remaining 22 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.

What are the compliance gaps when mapping IEC 62304:2015 Medical Device Software Lifecycle Processes to NIST SP 800-82 Rev 3 — Guide to OT Security?

22 IEC 62304:2015 Medical Device Software Lifecycle Processes controls have no direct equivalent in NIST SP 800-82 Rev 3 — Guide to OT Security. The highest concentration of gaps is in Clause 9 — Software Problem Resolution Process with 7 unmapped controls. These gaps represent areas where additional controls, policies, or documentation must be created to achieve compliance with both frameworks.

Which control domains have the most gaps between IEC 62304:2015 Medical Device Software Lifecycle Processes and NIST SP 800-82 Rev 3 — Guide to OT Security?

The domain with the highest gap count is Clause 9 — Software Problem Resolution Process (7 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.

Related Resources

How to Map Controls Across Frameworks|Multi-Framework Compliance Guide|Compliance Glossary

This platform provides educational compliance tools, not legal, regulatory, or professional compliance advice. Cross-framework mappings are AI-assisted interpretations and do not reproduce or replace official standards. Framework names and trademarks belong to their respective owners. Consult qualified professionals for your specific compliance requirements. See our Terms of Service.