Build, review and maintain your MDR technical documentation in one AI-assisted workspace, with specialist support when you need it.
Your EU MDR technical file has to show a notified body, in one consistent set of documents, that your device is safe and performs as intended. For most small and mid-sized manufacturers that evidence is scattered across Word files, spreadsheets and SharePoint folders. Obodux brings it into one structured workspace, helps you draft the missing pieces with AI, and gives you specialist review when you need it.
It is built for teams preparing a first MDR technical file, migrating a legacy MDD file to MDR, or keeping an existing file current between notified body audits.
Every part of the technical file, in one place
Obodux follows the structure of MDR Annex II (technical documentation) and Annex III (post-market surveillance), so each section has a home and nothing is left out by accident.
Device description and specification
Intended purpose, variants, accessories, classification rationale and UDI information.
Labelling and IFU
Labels, instructions for use and translations, linked to the device they belong to.
Design and manufacturing
Design stages, manufacturing sites, suppliers and key processes.
GSPR checklist
Each General Safety and Performance Requirement mapped to the standards and evidence that address it.
Risk management (ISO 14971)
Risk management plan, hazard analysis and risk-benefit conclusions, kept consistent with the rest of the file.
Clinical evaluation
Clinical evaluation plan and report, with literature and clinical data organised for review.
Verification and validation
Test reports for biocompatibility, electrical safety, software, usability and performance.
Post-market surveillance
PMS plan, PSUR or PMS report and PMCF, so the file stays live after certification.
How it works
Bring in what you already have
Upload your existing documents, however scattered. Obodux organises them against the Annex II structure.
See the gaps
Start with a free gap analysis showing how your documents map to the MDR structure, including missing or referenced-but-absent documents.
Draft with AI assistance
Use guided templates and AI drafting to fill the gaps. Every suggestion is yours to review, edit and approve.
Get specialist review
Ask Obodux regulatory specialists to review the sections that matter most, when you need a second pair of eyes.
Keep it current
Role-based access, version history and a full audit trail keep the file inspection-ready as your device and evidence change.
Obodux compared with the usual approaches
| Word and SharePoint | Consultant only | Obodux | |
|---|---|---|---|
| Structure | Folder structure you design and maintain | Depends on the consultant | Built around MDR Annex II and III |
| Finding gaps | Manual cross-checking | Paid review, usually point in time | Gap analysis whenever you need it |
| Drafting | From scratch or old templates | Written for you, at day rates | AI-assisted drafting your team controls |
| Expert input | None built in | Yes | Specialist review when you need it |
| Audit trail | Limited version history | Held by the consultant | Full change history in one workspace |
Who it is for
- Small and mid-sized medical device manufacturers in the UK and EU
- RA/QA leads and founders preparing for a notified body review
- Teams migrating legacy MDD devices before the MDR transition deadlines
- Manufacturers who also need a UKCA technical file for Great Britain
Common questions
Does Obodux replace our ISO 13485 QMS?
No. Obodux sits alongside your quality management system and focuses on the technical documentation. Your QMS procedures and document control stay as they are.
Can Obodux help us move an MDD technical file to MDR?
Yes. Import your MDD file, run a gap analysis against the MDR structure, and work through the gaps with AI drafting and specialist review. Our guide to MDR and IVDR transition deadlines explains the timelines.
Will using Obodux guarantee CE marking?
No. Obodux is a documentation tool with optional specialist review. It does not provide legal or regulatory advice, and your organisation remains responsible for its technical documentation and submissions.
How do we try it?
Request a 4-week free trial. We review each request and aim to confirm access within 48 business hours.
Start your MDR technical file with Obodux
Try Obodux free for 4 weeks, or start with a free gap analysis of your current file.
Start 4-week free trialGet a free gap analysisObodux is a documentation tool from BORIS Software Ltd. It does not provide legal or regulatory advice and does not guarantee CE, UKCA or any other approval. AI suggestions are guidance only, and manufacturers remain responsible for their technical documentation. Further reading: What is an EU MDR technical file?
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