Products
Integrated modules for your MDR technical documentation.
All our modules draw on the same up-to-date pool of regulations and standards. We begin the journey with GSPR and keep growing the ecosystem with the other parts of the technical file.
Available today
Modules you can use in the panel right nowGSPR Generation
In useStart with a 33-step sectioned questionnaire and produce your source-backed, line-by-line traceable GSPR output as a Word document right away.
See details →Regulatory Analysis
In useYour questions are first searched in the regulatory pool; the AI answers only from the passages found, giving each a source number.
See details →Regulatory Chat
In useA safe, MDR- and medical-device-focused interaction space inside the panel.
See details →Flows in development
A quality-assurance cycle for your existing documentsGSPR / Document Review & Analysis
In developmentScans your generated or existing GSPR matrix with an auditor's eye; lists rows lacking evidence or a standard reference as findings.
See details →Smart Document Correction
In developmentUses review and analysis findings to automatically improve the missing or faulty sections of your document in line with MDR rules. (Coming soon)
See details →Multilingual Document Adaptation (Translation)
In developmentTranslation of your technical documentation into the target-market language, fully aligned with medical-device terminology. (Coming soon)
See details →Roadmap — MDR Technical Documentation Modules
The technical-file sections in MDR Annex II and III. GSPR is done; the others are planned.- Annex II · Section 1 Device Description and Specification Planned
- Annex II · Section 2 Information to be Supplied by the Manufacturer Planned
- Annex II · Section 3 Design and Manufacturing Information Planned
- Annex II · Section 4 General Safety and Performance Requirements (GSPR) DoneLive via GSPR Generation →
- Annex II · Section 5 Benefit-Risk Analysis and Risk Management Planned
- Annex II · Section 6 Product Verification and Validation Planned
- Annex III Post-Market Surveillance (PMS) Planned