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MDR · IVDR · EU AI Act
The AI-native QMS and PLM platform for medical AI. Manage development, regulatory pathway and quality in one place: reach the market sooner, and stay compliant with less effort.
MDR, IVDR and the EU AI Act were designed to fit together. But the rules keep evolving, and so does your model. The teams that win keep compliance moving as fast as their product.
Estimates based on customer projects.
Evidify brings your product lifecycle (PLM) and quality management system (QMS) into one platform, so development, regulatory pathway and quality move forward together. And we're the right partner for ISO 13485, ISO 42001, ISO 27001 and ISO 9001.
Create evidence once and reuse it across MDR, IVDR, the AI Act, FDA clearances and ISO standards.
Holmes identifies clinical and AI risks and proposes the right controls.
Evidence flows in from GitHub and the tools your engineers already use.
Your QMS keeps up as models retrain and products evolve, so staying compliant takes less effort.
1. Know where you stand. One assessment gives you your MDR/IVDR class and AI Act risk tier.
2. Know what to do. Holmes maps your clinical and AI risks and the controls they need.
3. Do it. Procedures are routed, signed and enforced, with Part 11 e-signatures.
4. Prove it. Live traceability from user needs to tests, with evidence from your engineering tools.
5. Keep proving it. Model retrains, complaints and CAPAs are captured as they happen.
Holmes combines deep knowledge of MDR, IVDR, the EU AI Act and the ISO standards behind them with everything in your workspace: your products, risks, data and documents. So its guidance fits your device, not a generic template.
It tells you what applies and what comes next, and drafts risk analyses, procedures and technical documentation for your team to finalise.
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