Your Fast-Track to Compliance.

We handle your ISO 13485 and ISO 14971 documentation, so you can bring your medical device to market faster.

What we cover?

    • Done-for-You Risk Management File (RMF): We deliver a complete, audit-ready Risk Management File tailored to your product, including Risk Analysis, Evaluation, and Control measures.

    • AI-Powered Documentation: Our AI engine automatically builds and updates your risk documents by ingesting data from your existing design and development files, saving you hundreds of hours of manual work.

    • Expert Sign-Off: Our regulatory consultant reviews and approves every document, providing you with the certainty and confidence that your RMF is compliant and ready for your auditor.

    • Systematic Risk Traceability: We ensure every identified risk is properly traced to its controls and verified, creating a complete and defensible record.

    • Done-for-You QMS Documentation: We develop and deliver your complete Quality Management System, including all required procedures, policies, and templates.

    • Audit-Ready Documents: We ensure every document is complete, linked, and ready for your official audit.

    • Expert Review & Sign-Off: All documentation is reviewed and approved by our regulatory expert, providing you with certainty and peace of mind.

    • We provide fractional Clinical Safety Officer, Regulatory Consultant, PPI/E consulting and all the expertise you need to be compliant.

  • Capture and document nonconformities as they happen — no manual tracking required.

    We integrates with Jira and Slack to generate structured, compliant records into Notion, Google doc, Word, including:

    • Issue detection and categorization

    • Root cause and corrective actions

    • Linked evidence and resolution history

    • Audit-ready nonconformity logs

    • Ongoing status tracking

    Stay inspection-ready without relying on spreadsheets or missed follow-ups.

Why we built this

After years of battling the chaos of documentation black holes, messy project handovers, and the nightmare of reverse-engineering someone’s half-forgotten masterpiece, we knew something had to change. That’s why we built this product, to rescue teams from the trap of low-value busywork and give them the freedom to focus on creativity and innovation. Our mission? To help teams launch well-documented, safe products with ease, and even save you money along the way. Learn more

Contact Us

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