AI Assurance DirectoryCompliance automation
Greenlight Guru (SiMD/SaMD)
Evidence strength: Moderate How this is scored
QMS and product-development software for software-enabled medical devices (SiMD/SaMD). Official page says the solution auto-generates audit-ready records to stay compliant with IEC 62304, linking tests and design changes to the DHF. Not an FDA PCCP authoring product.
Certification evidence
Maps to 1 IEC 62304 requirement — see which with Pro
Certification relevance. Cited pages map this listing to IEC 62304 (1 requirement).
Cited page: SiMD/SaMD Product Development & QMS Software | Greenlight Guru — 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
- Greenlight Guru
- Type
- Commercial
- Official site
- https://www.greenlight.guru/productdevelopment-simd-samd
- 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.