• 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.