Cross-Framework Mapping

IEC 62304:2015 Medical Device Software Lifecycle ProcessesvsISO 14064 - Greenhouse Gas Accounting and Verification (Parts 1-3)

See exactly how IEC 62304:2015 Medical Device Software Lifecycle Processes controls map to ISO 14064 - Greenhouse Gas Accounting and Verification (Parts 1-3). Pre-computed mappings, identified gaps, and coverage analysis.

8
Controls Mapped
25
Gaps Found
15%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

IEC 62304:2015 Medical Device Software Lifecycle Processes maps to ISO 14064 - Greenhouse Gas Accounting and Verification (Parts 1-3) with 15% coverage across 8 directly mapped controls. Analysis of 33 IEC 62304:2015 Medical Device Software Lifecycle Processes controls identifies 42 compliance gaps — primarily concentrated in Clause 9 - Software Problem Resolution Process.

Source: TheArtOfService Knowledge Graph | 33 controls analysed | 706 frameworks | 324K+ cross-framework mappings

Control Mappings

Showing 8 of 8 mapped controls across 7 domains. Sign up to explore all 324K+ mappings across 706 frameworks.

Clause 4 - General Requirements(1 mappings)

IEC62304-4.1Quality Management System
ISO-14064-1-8Quality management of the GHG inventory

Requirements(1 mappings)

IEC62304-5.2Software Requirements Analysis
ISO-14064-1-5.1Organizational boundaries

Clause 5 - Software Development Process(2 mappings)

IEC62304-5.2Software Requirements Analysis
ISO-14064-1-5.1Organizational boundaries
IEC62304-5.3Software Architectural Design
ISO-14064-1-5.1Organizational boundaries

Design(1 mappings)

IEC62304-5.3Software Architectural Design
ISO-14064-1-5.1Organizational boundaries

Risk Management(1 mappings)

IEC62304-7.2Risk Control Measures
ISO-14064-1-5.1Organizational boundaries

Clause 7 - Software Risk Management Process(1 mappings)

IEC62304-7.2Risk Control Measures
ISO-14064-1-5.1Organizational boundaries

Clause 9 - Software Problem Resolution Process(1 mappings)

IEC62304-9.6Analyze Problems for Trends
ISO-14064-1-8Quality management of the GHG inventory

Related Comparisons

Other IEC 62304:2015 Medical Device Software Lifecycle Processes comparisons

Other ISO 14064 - Greenhouse Gas Accounting and Verification (Parts 1-3) comparisons

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What are the key differences between IEC 62304:2015 Medical Device Software Lifecycle Processes and ISO 14064 - Greenhouse Gas Accounting and Verification (Parts 1-3)?

IEC 62304:2015 Medical Device Software Lifecycle Processes has 33 controls across its framework, while ISO 14064 - Greenhouse Gas Accounting and Verification (Parts 1-3) covers 42 controls. Direct mapping analysis identifies 8 overlapping controls (15% 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 ISO 14064 - Greenhouse Gas Accounting and Verification (Parts 1-3) equivalent.

How many controls map between IEC 62304:2015 Medical Device Software Lifecycle Processes and ISO 14064 - Greenhouse Gas Accounting and Verification (Parts 1-3)?

Of 33 total IEC 62304:2015 Medical Device Software Lifecycle Processes controls, 8 map directly to ISO 14064 - Greenhouse Gas Accounting and Verification (Parts 1-3) controls — representing 15% coverage. The remaining 42 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 ISO 14064 - Greenhouse Gas Accounting and Verification (Parts 1-3)?

42 IEC 62304:2015 Medical Device Software Lifecycle Processes controls have no direct equivalent in ISO 14064 - Greenhouse Gas Accounting and Verification (Parts 1-3). 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 ISO 14064 - Greenhouse Gas Accounting and Verification (Parts 1-3)?

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.

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