Cross-Framework Mapping

IEC 62304:2015 Medical Device Software Lifecycle ProcessesvsNRF Cybersecurity and Data Privacy Framework (National Retail Federation)

See exactly how IEC 62304:2015 Medical Device Software Lifecycle Processes controls map to NRF Cybersecurity and Data Privacy Framework (National Retail Federation). Pre-computed mappings, identified gaps, and coverage analysis.

11
Controls Mapped
22
Gaps Found
15%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

IEC 62304:2015 Medical Device Software Lifecycle Processes maps to NRF Cybersecurity and Data Privacy Framework (National Retail Federation) with 15% coverage across 7 directly mapped controls. Analysis of 33 IEC 62304:2015 Medical Device Software Lifecycle Processes controls identifies 43 compliance gaps — primarily concentrated in Clause 5 - Software Development Process.

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

Control Mappings

Showing 11 of 11 mapped controls across 7 domains. Sign up to explore all 332K+ mappings across 718 frameworks.

Clause 4 - General Requirements(2 mappings)

IEC62304-4.1Quality Management System2 targets
NRFCS-1Retail Cybersecurity Governance, Policy, and Regulatory Change Management
NRFCS-2Risk Assessment, Customer Data Inventory, Classification, and Retail Threat Model

Clause 5 - Software Development Process(2 mappings)

IEC62304-5.1Software Development Planning2 targets
NRFCS-1Retail Cybersecurity Governance, Policy, and Regulatory Change Management
NRFCS-2Risk Assessment, Customer Data Inventory, Classification, and Retail Threat Model

Risk Management(2 mappings)

IEC62304-7.4Risk Management of Software Changes2 targets
NRFCS-1Retail Cybersecurity Governance, Policy, and Regulatory Change Management
NRFCS-2Risk Assessment, Customer Data Inventory, Classification, and Retail Threat Model

Clause 7 - Software Risk Management Process(2 mappings)

IEC62304-7.4Risk Management of Software Changes2 targets
NRFCS-1Retail Cybersecurity Governance, Policy, and Regulatory Change Management
NRFCS-2Risk Assessment, Customer Data Inventory, Classification, and Retail Threat Model

Configuration(1 mappings)

IEC62304-8.2Change Control
NRFCS-1Retail Cybersecurity Governance, Policy, and Regulatory Change Management

Clause 8 - Software Configuration Management Process(1 mappings)

IEC62304-8.2Change Control
NRFCS-1Retail Cybersecurity Governance, Policy, and Regulatory Change Management

Clause 9 - Software Problem Resolution Process(1 mappings)

IEC62304-9.4Use Change Control Process
NRFCS-1Retail Cybersecurity Governance, Policy, and Regulatory Change Management

Related Comparisons

Other IEC 62304:2015 Medical Device Software Lifecycle Processes comparisons

Other NRF Cybersecurity and Data Privacy Framework (National Retail Federation) comparisons

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What are the key differences between IEC 62304:2015 Medical Device Software Lifecycle Processes and NRF Cybersecurity and Data Privacy Framework (National Retail Federation)?

IEC 62304:2015 Medical Device Software Lifecycle Processes has 33 controls across its framework, while NRF Cybersecurity and Data Privacy Framework (National Retail Federation) covers 8 controls. Direct mapping analysis identifies 7 overlapping controls (15% coverage). The frameworks diverge most significantly in Clause 5 - Software Development Process, where 7 IEC 62304:2015 Medical Device Software Lifecycle Processes controls have no direct NRF Cybersecurity and Data Privacy Framework (National Retail Federation) equivalent.

How many controls map between IEC 62304:2015 Medical Device Software Lifecycle Processes and NRF Cybersecurity and Data Privacy Framework (National Retail Federation)?

Of 33 total IEC 62304:2015 Medical Device Software Lifecycle Processes controls, 7 map directly to NRF Cybersecurity and Data Privacy Framework (National Retail Federation) controls — representing 15% coverage. The remaining 43 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 NRF Cybersecurity and Data Privacy Framework (National Retail Federation)?

43 IEC 62304:2015 Medical Device Software Lifecycle Processes controls have no direct equivalent in NRF Cybersecurity and Data Privacy Framework (National Retail Federation). The highest concentration of gaps is in Clause 5 - Software Development 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 NRF Cybersecurity and Data Privacy Framework (National Retail Federation)?

The domain with the highest gap count is Clause 5 - Software Development Process (7 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.

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