MDS2 (Medical Device)vsISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence
See exactly how MDS2 (Medical Device) controls map to ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence. Pre-computed mappings, identified gaps, and coverage analysis.
According to the TheArtOfService Compliance Knowledge Graph:
MDS2 (Medical Device) maps to ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence with 38% coverage across 3 directly mapped controls. Analysis of 8 MDS2 (Medical Device) controls identifies 5 compliance gaps — primarily concentrated in Roadmap Third Party Security Guidance and Vulnerability Disclosure - MDS2.
Source: TheArtOfService Knowledge Graph | 8 controls analysed | 718 frameworks | 332K+ cross-framework mappings
Control Mappings
Showing 14 of 14 mapped controls across 3 domains. Sign up to explore all 332K+ mappings across 718 frameworks.
Audit Logging Integrity and Cybersecurity Risk - MDS2(3 mappings)
PHI Data Handling Storage and Transmission - MDS2(6 mappings)
Authentication and Authorization - MDS2(5 mappings)
Related Comparisons
Other MDS2 (Medical Device) comparisons
Other ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence comparisons
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What are the key differences between MDS2 (Medical Device) and ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence?
MDS2 (Medical Device) has 8 controls across its framework, while ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence covers 77 controls. Direct mapping analysis identifies 3 overlapping controls (38% coverage). The frameworks diverge most significantly in Roadmap Third Party Security Guidance and Vulnerability Disclosure - MDS2, where 1 MDS2 (Medical Device) controls have no direct ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence equivalent.
How many controls map between MDS2 (Medical Device) and ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence?
Of 8 total MDS2 (Medical Device) controls, 3 map directly to ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence controls — representing 38% coverage. The remaining 5 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.
What are the compliance gaps when mapping MDS2 (Medical Device) to ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence?
5 MDS2 (Medical Device) controls have no direct equivalent in ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence. The highest concentration of gaps is in Roadmap Third Party Security Guidance and Vulnerability Disclosure - MDS2 with 1 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 MDS2 (Medical Device) and ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence?
The domain with the highest gap count is Roadmap Third Party Security Guidance and Vulnerability Disclosure - MDS2 (1 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.
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