AI Assurance DirectoryCompliance automation
ComplianceQuest Medical Device QMS
Evidence strength: Moderate How this is scored
Salesforce-native QMS and PLM for medical device manufacturers. Official SaMD page names FDA Predetermined Change Control Plans (PCCP), IEC 62304 lifecycle requirements, cybersecurity documentation and IMDRF SaMD guidance. Not a model verifier.
Certification evidence
Maps to 1 IEC 62304 requirement — see which with Pro
Maps to 1 FDA AI-DSF / PCCP recommendation — see which with Pro
Certification relevance. Cited pages map this listing to IEC 62304 (1 requirement) and FDA AI-DSF / PCCP (1 recommendation).
Cited page: ComplianceQuest: Medical Devices — a named IEC 62304 requirement.
Cited page · The quoted wording is Pro.
Listing detail and source evidence (Pro)
Included on Pro, Team and Enterprise. Public summaries, tags and official links on this page stay free.
Cited mappings (Pro)
Included on Pro, Team and Enterprise. Public summaries, tags and official links on this page stay free.
Procurement evidence pack (Pro) — print cited mappings and analyst notes. The print view is not on this page.
- Vendor / publisher
- ComplianceQuest
- Type
- Commercial
- Official site
- https://www.compliancequest.com/medical-device/
- Industries
- Frameworks named on cited source
- Last verified
Listing is not an endorsement, certification or recommendation. Capabilities, availability and framework support can change. Confirm with the vendor and the relevant authority. See the disclaimer.