• ComplianceQuest Medical Device QMS

  ComplianceQuest · Commercial · Compliance automation

  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.

  • Medical devices
  • FDA AI-DSF / PCCP
  • IEC 62304

• ENVOLOK

  ENVOLOK · Commercial · Compliance automation

  Command-line program that checks a modification against an FDA-authorized Predetermined Change Control Plan before it ships. Official page: DEPLOY, BLOCK or UNKNOWN; offline; no network calls during evaluation. Not a QMS or model verifier.

  • Medical devices
  • FDA AI-DSF / PCCP

Official documents and working-group pages

These are the primary public pages we cite for FDA AI-DSF / PCCP. They are not directory listings and are not endorsements.

Sources last checked on 15 October 2026.

1. Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations - FDA
2. Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions - FDA
3. IEC 62304:2006 - Medical device software — Software life cycle processes - IEC

Related articles

• FDA’s List of Artificial Intelligence-Enabled Medical Devices — what it is and is not
• FDA Good Machine Learning Practice guiding principles — what the page says
• IEC 62304 and FDA PCCP — two ways of talking about changes to AI device software
• Medical-device AI — FDA PCCP, IEC 62304 and EU MDR plus the AI Act
• Medical device ML — what evidence does FDA expect in a submission?

Questions

Why are there so few commercial tools tagged for FDA AI-DSF / PCCP?

We only tag a tool when the cited public page names this framework (or, for SAE G-34, EUROCAE WG-114, ED-324 or ARP6983). We do not infer support from a related aviation standard.

Where are the official FDA AI-DSF / PCCP documents?

The official documents and working-group pages are listed on this page and on the FDA AI-DSF / PCCP explainer.

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