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IEC 62304:2015 Medical Device Software Lifecycle ProcessesvsNIST SP 800-82 Revision 3: Guide to Industrial Control Systems (ICS) Security

See exactly how IEC 62304:2015 Medical Device Software Lifecycle Processes controls map to NIST SP 800-82 Revision 3: Guide to Industrial Control Systems (ICS) Security. Pre-computed mappings, identified gaps, and coverage analysis.

24
Controls Mapped
9
Gaps Found
24%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

IEC 62304:2015 Medical Device Software Lifecycle Processes maps to NIST SP 800-82 Revision 3: Guide to Industrial Control Systems (ICS) Security with 24% coverage across 13 directly mapped controls. Analysis of 33 IEC 62304:2015 Medical Device Software Lifecycle Processes controls identifies 37 compliance gaps — primarily concentrated in Clause 9 - Software Problem Resolution Process.

Source: TheArtOfService Knowledge Graph | 33 controls analysed | 718 frameworks | 332K+ cross-framework mappings

Control Mappings

Showing 20 of 24 mapped controls across 9 domains. Sign up to explore all 332K+ mappings across 718 frameworks.

Clause 4 - General Requirements(2 mappings)

IEC62304-4.1Quality Management System2 targets
→NISTSP82-1OT Security Program Governance, Policy, Roles, and Safety-Security Integration
→NISTSP82-5OT Configuration Management, Patching, Vulnerability Management, and Malware Protection

Clause 5 - Software Development Process(6 mappings)

IEC62304-5.1Software Development Planning2 targets
→NISTSP82-1OT Security Program Governance, Policy, Roles, and Safety-Security Integration
→NISTSP82-5OT Configuration Management, Patching, Vulnerability Management, and Malware Protection
IEC62304-5.2Software Requirements Analysis2 targets
→NISTSP82-1OT Security Program Governance, Policy, Roles, and Safety-Security Integration
→NISTSP82-7OT Incident Response, Forensics, Recovery, and Continuity
IEC62304-5.3Software Architectural Design2 targets
→NISTSP82-1OT Security Program Governance, Policy, Roles, and Safety-Security Integration
→NISTSP82-7OT Incident Response, Forensics, Recovery, and Continuity

Requirements(2 mappings)

IEC62304-5.2Software Requirements Analysis2 targets
→NISTSP82-1OT Security Program Governance, Policy, Roles, and Safety-Security Integration
→NISTSP82-7OT Incident Response, Forensics, Recovery, and Continuity

Design(2 mappings)

IEC62304-5.3Software Architectural Design2 targets
→NISTSP82-1OT Security Program Governance, Policy, Roles, and Safety-Security Integration
→NISTSP82-7OT Incident Response, Forensics, Recovery, and Continuity

Risk Management(3 mappings)

IEC62304-7.2Risk Control Measures2 targets
→NISTSP82-1OT Security Program Governance, Policy, Roles, and Safety-Security Integration
→NISTSP82-7OT Incident Response, Forensics, Recovery, and Continuity
IEC62304-7.4Risk Management of Software Changes
→NISTSP82-1OT Security Program Governance, Policy, Roles, and Safety-Security Integration

Clause 7 - Software Risk Management Process(3 mappings)

IEC62304-7.2Risk Control Measures2 targets
→NISTSP82-1OT Security Program Governance, Policy, Roles, and Safety-Security Integration
→NISTSP82-7OT Incident Response, Forensics, Recovery, and Continuity
IEC62304-7.4Risk Management of Software Changes
→NISTSP82-1OT Security Program Governance, Policy, Roles, and Safety-Security Integration

Configuration(2 mappings)

IEC62304-8.2Change Control2 targets
→NISTSP82-5OT Configuration Management, Patching, Vulnerability Management, and Malware Protection
→NISTSP82-6OT Audit, Monitoring, Anomaly Detection, and OT-Specific SOC

+4 more mappings

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Related Comparisons

Other IEC 62304:2015 Medical Device Software Lifecycle Processes comparisons

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Other NIST SP 800-82 Revision 3: Guide to Industrial Control Systems (ICS) Security comparisons

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What are the key differences between IEC 62304:2015 Medical Device Software Lifecycle Processes and NIST SP 800-82 Revision 3: Guide to Industrial Control Systems (ICS) Security?

IEC 62304:2015 Medical Device Software Lifecycle Processes has 33 controls across its framework, while NIST SP 800-82 Revision 3: Guide to Industrial Control Systems (ICS) Security covers 8 controls. Direct mapping analysis identifies 13 overlapping controls (24% 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 Revision 3: Guide to Industrial Control Systems (ICS) Security equivalent.

How many controls map between IEC 62304:2015 Medical Device Software Lifecycle Processes and NIST SP 800-82 Revision 3: Guide to Industrial Control Systems (ICS) Security?

Of 33 total IEC 62304:2015 Medical Device Software Lifecycle Processes controls, 13 map directly to NIST SP 800-82 Revision 3: Guide to Industrial Control Systems (ICS) Security controls — representing 24% coverage. The remaining 37 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 Revision 3: Guide to Industrial Control Systems (ICS) Security?

37 IEC 62304:2015 Medical Device Software Lifecycle Processes controls have no direct equivalent in NIST SP 800-82 Revision 3: Guide to Industrial Control Systems (ICS) 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 Revision 3: Guide to Industrial Control Systems (ICS) 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

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