Cross-Framework Mapping

NIST SP 800-171A Rev 3 - Assessing CUI Security RequirementsvsIEC 62304:2015 Medical Device Software Lifecycle Processes

See exactly how NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements controls map to IEC 62304:2015 Medical Device Software Lifecycle Processes. Pre-computed mappings, identified gaps, and coverage analysis.

24
Controls Mapped
11
Gaps Found
29%
Coverage

Need this as a report you can hand to an assessor? A coverage crosswalk for this pair can be built to order.

According to the TheArtOfService Compliance Knowledge Graph:

NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements maps to IEC 62304:2015 Medical Device Software Lifecycle Processes with 29% coverage across 10 directly mapped controls. Analysis of 35 NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements controls identifies 25 compliance gaps, primarily concentrated in System Protection and Communications.

Source: TheArtOfService Knowledge Graph | 35 controls analysed | 686 frameworks | 310K+ cross-framework mappings

Control Mappings

Showing 20 of 24 mapped controls across 5 domains. Sign up to explore all 310K+ mappings across 686 frameworks.

Access Control and Identification(3 mappings)

3.1Physical Security3 targets
IEC62304-4.1Quality Management System
IEC62304-5.1Software Development Planning
IEC62304-9.6Analyze Problems for Trends

Incident Response and Media Protection(6 mappings)

3.16System and Services Acquisition3 targets
IEC62304-4.1Quality Management System
IEC62304-5.1Software Development Planning
IEC62304-7.4Risk Management of Software Changes
3.17Supply Chain Risk Management3 targets
IEC62304-4.1Quality Management System
IEC62304-5.1Software Development Planning
IEC62304-7.4Risk Management of Software Changes

Awareness, Training, and Personnel(1 mappings)

3.2Establish and Maintain a Data Inventory
IEC62304-5.1Software Development Planning

Audit, Assessment, and Monitoring(4 mappings)

3.3Configure Data Access Control Lists3 targets
IEC62304-5.2Software Requirements Analysis
IEC62304-5.3Software Architectural Design
IEC62304-7.2Risk Control Measures
3.4Enforce Data Retention
IEC62304-5.1Software Development Planning

System Protection and Communications(6 mappings)

FEDRAMP-CM-1Configuration Management Policy2 targets
IEC62304-4.1Quality Management System
IEC62304-5.1Software Development Planning
FEDRAMP-CM-2Baseline Configuration2 targets
IEC62304-4.1Quality Management System
IEC62304-5.1Software Development Planning
FEDRAMP-CM-6Configuration Settings2 targets
IEC62304-5.2Software Requirements Analysis
IEC62304-5.3Software Architectural Design

+4 more mappings

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Coverage crosswalk

A NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements to IEC 62304:2015 Medical Device Software Lifecycle Processes crosswalk, built to order

The table above lists candidate mappings. A crosswalk answers the narrower question you are probably here for: which IEC 62304:2015 Medical Device Software Lifecycle Processes controls your existing NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements work already satisfies, which are real gaps, and the reasoning behind every claim so you can check it. One pair, $299, one time.

NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements into IEC 62304:2015 Medical Device Software Lifecycle Processes
Not published yet

This direction has not been through crosswalk review and sign off, so no coverage figure is published for it. Reporting an unreviewed number would be worse than reporting none. It can be built to order at the same price as a pair that is already on the shelf.

If the two frameworks turn out to have too little in common for a crosswalk to help you, we say so and refund it rather than send a number worth nothing.

IEC 62304:2015 Medical Device Software Lifecycle Processes into NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements
Not published yet

This direction has not been through crosswalk review and sign off, so no coverage figure is published for it. Reporting an unreviewed number would be worse than reporting none. It can be built to order at the same price as a pair that is already on the shelf.

If the two frameworks turn out to have too little in common for a crosswalk to help you, we say so and refund it rather than send a number worth nothing.

NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements to IEC 62304:2015 Medical Device Software Lifecycle Processes (built to order)
$299
per framework pair, one time
  • Every evidenced control, with the reasoning behind it
  • Every gap, with what it requires
  • Its level of review stated plainly, not a bare number

Why this page shows two different percentages. The 29% in the header counts how many NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements controls carry at least one candidate mapping in the graph, before any review. The crosswalk percentage counts something stricter: how many IEC 62304:2015 Medical Device Software Lifecycle Processes controls are actually evidenced, after a pass that argued against each mapping and kept only what survived. They answer different questions and they are not meant to agree.

A crosswalk narrows the work. It does not replace an audit, and your assessor may take a different view on individual controls. Mappings between frameworks are judgements, not text printed in either standard, which is why every claim in the report shows its reasoning. Questions go to support@theartofservice.com.

Related Comparisons

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Other IEC 62304:2015 Medical Device Software Lifecycle Processes comparisons

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What are the key differences between NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements and IEC 62304:2015 Medical Device Software Lifecycle Processes?

NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements has 35 controls across its framework, while IEC 62304:2015 Medical Device Software Lifecycle Processes covers 33 controls. Direct mapping analysis identifies 10 overlapping controls (29% coverage). The frameworks diverge most significantly in System Protection and Communications, where 11 NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements controls have no direct IEC 62304:2015 Medical Device Software Lifecycle Processes equivalent.

How many controls map between NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements and IEC 62304:2015 Medical Device Software Lifecycle Processes?

Of 35 total NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements controls, 10 map directly to IEC 62304:2015 Medical Device Software Lifecycle Processes controls, representing 29% coverage. The remaining 25 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.

What are the compliance gaps when mapping NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements to IEC 62304:2015 Medical Device Software Lifecycle Processes?

25 NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements controls have no direct equivalent in IEC 62304:2015 Medical Device Software Lifecycle Processes. The highest concentration of gaps is in System Protection and Communications with 11 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 800-171A Rev 3 - Assessing CUI Security Requirements and IEC 62304:2015 Medical Device Software Lifecycle Processes?

The domain with the highest gap count is System Protection and Communications (11 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.