# Design Dossier Elaborator

> Guided elaboration of design dossier, technical file, or device master record sections for medical devices: device classification, risk summary (ISO 14971:2019), essential principles (GSPR), labelling/IFU, clinical evaluation, post-market surveillance, and traceability per EU MDR 2017/745 Annex II and FDA QMSR (21 CFR Part 4).



Tags: Medical Devices, ISO 13485, EU MDR, FDA, Technical Documentation, Compliance, ISO 14971, GSPR, IEC 62304, IEC 62366


## Example Prompts

- Structure our technical file per MDR Annex II with risk summary and GSPR
- Draft the risk summary and ensure traceability to our ISO 14971:2019 risk management file
- Check that required annex sections are present and traceable to risk and standards
- Help draft the clinical evaluation section and post-market surveillance plan
- What device classification applies under MDR Annex VIII and which conformity assessment route does that require?

URL: https://rakenne.app/skills/design-dossier-elaborator/index.md

Try this skill: https://rakenne.app/a/?skill=design-dossier-elaborator


## 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.


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