ISO 13485:2016vsCOPPA
See exactly how ISO 13485:2016 controls map to COPPA. Pre-computed mappings, identified gaps, and coverage analysis.
According to the TheArtOfService Compliance Knowledge Graph:
ISO 13485:2016 maps to COPPA with 1% coverage across 1 directly mapped controls. Analysis of 83 ISO 13485:2016 controls identifies 82 compliance gaps — primarily concentrated in Product realization – ISO 13485:2016.
Source: TheArtOfService Knowledge Graph | 83 controls analysed | 718 frameworks | 332K+ cross-framework mappings
Control Mappings
Showing 1 of 1 mapped controls across 1 domains. Sign up to explore all 332K+ mappings across 718 frameworks.
Quality management system – ISO 13485:2016(1 mappings)
Related Comparisons
Other ISO 13485:2016 comparisons
Stop Paying Consultants to Read Spreadsheets
AI-powered compliance intelligence across 718 frameworks — at a fraction of consulting costs.
Free
- ✓ 718 framework browser
- ✓ Cross-framework mappings (332K+)
- ✓ 824 compliance assessments
- ✓ 3 AI queries & searches per day
Professional
- ✓ Unlimited AI Compliance Advisory
- ✓ Unlimited full-text search
- ✓ Framework self-assessment
- ✓ PDF, Excel & CSV exports
What are the key differences between ISO 13485:2016 and COPPA?
ISO 13485:2016 has 83 controls across its framework, while COPPA covers 21 controls. Direct mapping analysis identifies 1 overlapping controls (1% coverage). The frameworks diverge most significantly in Product realization – ISO 13485:2016, where 33 ISO 13485:2016 controls have no direct COPPA equivalent.
How many controls map between ISO 13485:2016 and COPPA?
Of 83 total ISO 13485:2016 controls, 1 map directly to COPPA controls — representing 1% coverage. The remaining 82 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.
What are the compliance gaps when mapping ISO 13485:2016 to COPPA?
82 ISO 13485:2016 controls have no direct equivalent in COPPA. The highest concentration of gaps is in Product realization – ISO 13485:2016 with 33 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 ISO 13485:2016 and COPPA?
The domain with the highest gap count is Product realization – ISO 13485:2016 (33 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.
Related Resources
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.