Design Dossier Elaborator

Medical Devices ISO 13485 EU MDR FDA Technical Documentation Compliance

Overview

Guided elaboration of design dossier, technical file, or device master record sections for medical devices: risk summary, essential principles (GSPR), labelling, and traceability to risk file and standards per MDR Annex II/III and FDA design control.

Getting Started

Add your source materials to the project workspace, then activate the Design Dossier Elaborator skill. The agent will guide you through the process step by step.

Example Conversation

You: We’re preparing the technical file for our Class IIa device under MDR. I need to ensure we have risk summary, essential principles, and labelling, and that they’re traceable to the risk file.
Agent: I’ll run check_annex_traceability on your technical documentation to see which required sections (risk summary, GSPR, labelling, device description) are present and whether risk/GSPR traceability is mentioned. Then we can fill any gaps.
Agent: The tool found all four section types. It noted that the risk section should be explicitly traceable to the risk management file (e.g. ISO 14971). I’ve added a “Traceability” subsection under Risk summary stating “This summary is derived from the risk management report [RM-2024-01] per ISO 14971” and a short GSPR table with a “Standard / evidence” column for each applicable GSPR.
You: Add a row for GSPR 1 (safety) and 10 (labelling).
Agent: Done. Re-run check_annex_traceability to confirm traceability warnings are addressed.

Sample Output Excerpt

Excerpt from a technical file showing risk summary traceability and GSPR table.

Risk summary

The device risk analysis was performed per ISO 14971. Residual risks are documented in the risk management report; benefit–risk determination is positive for all residual risks above acceptability criteria. Traceability: This summary is derived from risk management report RM-2024-01 (ISO 14971).

Essential principles (GSPR) — excerpt

GSPR	Requirement	Standard / evidence
1	Safety	ISO 14971 risk management; design verification.
10	Information and labelling	IFU and label per MDR Annex I 10.4; language versions.

Labelling and IFU

Labelling complies with MDR Annex I 10.4. IFU includes intended use, user profile, warnings, and maintenance. Consistent with risk control measures in the risk management file.

Built-in Validation Tools

The skill includes an extension tool that checks technical documentation for required sections and traceability.

What the tool checks

Check	`check_annex_traceability`
Required sections	Risk summary/risk management, Essential principles (GSPR), Labelling/IFU, Device description
Risk traceability	Looks for traceability, trace to, risk file, risk management report, ISO 14971
GSPR traceability	Looks for GSPR, essential principle, standard reference, compliance with
Findings	WARNING if a required section is missing or risk/GSPR traceability is weak; INFO when sections and traceability are found

Example validation output

======================================================================
DESIGN DOSSIER / TECHNICAL FILE TRACEABILITY REPORT
MDR Annex II/III, FDA Design Control
======================================================================
Document: technical-file/technical-documentation.md

--- FINDINGS ---
  [INFO] Section found: Risk summary / risk management.
  [INFO] Section found: Essential principles (GSPR).
  [WARNING] Risk section should be traceable to the risk management file (e.g. ISO 14971 risk management report). Add explicit traceability.

--- SUMMARY ---
  Errors: 0
  Warnings: 1
======================================================================

Run the tool on your design dossier, technical file, or device master record before notified body or authority submission.