Cross-Framework Mapping

NIST SP 800-82 Rev 3 — Guide to OT SecurityvsIEC 62304:2015 Medical Device Software Lifecycle Processes

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

17
Controls Mapped
4
Gaps Found
29%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

NIST SP 800-82 Rev 3 — Guide to OT Security maps to IEC 62304:2015 Medical Device Software Lifecycle Processes with 29% coverage across 6 directly mapped controls. Analysis of 21 NIST SP 800-82 Rev 3 — Guide to OT Security controls identifies 15 compliance gaps — primarily concentrated in OT Security Controls.

Source: TheArtOfService Knowledge Graph | 21 controls analysed | 693 frameworks | 819K+ cross-framework mappings

Control Mappings

Showing 17 of 17 mapped controls across 3 domains. Sign up to explore all 819K+ mappings across 693 frameworks.

OT Security Controls(6 mappings)

NIST82-CTL-03OT Audit and Monitoring2 targets
IEC62304-8.2Change Control
IEC62304-9.4Use Change Control Process
NIST82-CTL-05OT Configuration Management4 targets
IEC62304-4.1Quality Management System
IEC62304-5.1Software Development Planning
IEC62304-8.2Change Control
IEC62304-9.4Use Change Control Process

OT Incident Response(3 mappings)

NIST82-IR-03OT Incident Containment3 targets
IEC62304-5.2Software Requirements Analysis
IEC62304-5.3Software Architectural Design
IEC62304-7.2Risk Control Measures

OT Risk Management(8 mappings)

NIST82-RM-01OT-Specific Risk Management Framework3 targets
IEC62304-4.1Quality Management System
IEC62304-5.1Software Development Planning
IEC62304-7.4Risk Management of Software Changes
NIST82-RM-02OT Security Program Management3 targets
IEC62304-5.2Software Requirements Analysis
IEC62304-5.3Software Architectural Design
IEC62304-7.2Risk Control Measures
NIST82-RM-05OT Security Training and Awareness2 targets
IEC62304-4.1Quality Management System
IEC62304-5.1Software Development Planning

Related Comparisons

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

Other IEC 62304:2015 Medical Device Software Lifecycle Processes comparisons

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

NIST SP 800-82 Rev 3 — Guide to OT Security has 21 controls across its framework, while IEC 62304:2015 Medical Device Software Lifecycle Processes covers 30 controls. Direct mapping analysis identifies 6 overlapping controls (29% coverage). The frameworks diverge most significantly in OT Security Controls, where 5 NIST SP 800-82 Rev 3 — Guide to OT Security controls have no direct IEC 62304:2015 Medical Device Software Lifecycle Processes equivalent.

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

Of 21 total NIST SP 800-82 Rev 3 — Guide to OT Security controls, 6 map directly to IEC 62304:2015 Medical Device Software Lifecycle Processes controls — representing 29% coverage. The remaining 15 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.

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

15 NIST SP 800-82 Rev 3 — Guide to OT Security controls have no direct equivalent in IEC 62304:2015 Medical Device Software Lifecycle Processes. The highest concentration of gaps is in OT Security Controls with 5 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 NIST SP 800-82 Rev 3 — Guide to OT Security and IEC 62304:2015 Medical Device Software Lifecycle Processes?

The domain with the highest gap count is OT Security Controls (5 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.

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.