Technical File Creation (UKCA/MDR)
We organise the evidence, write the missing pieces, and deliver a clean, audit-ready Technical File
Who this is for
Early teams with a working prototype and scattered docs.
Founders who need a clear file structure and no-nonsense writing for UKCA/MDR.
Teams retrofitting documentation for market/partner diligence.
Anyone who wants a file that maps cleanly to evidence (not just a pile of PDFs).
Outcome: a single, navigable Technical File with links to the right evidence – ready for review.
What’s included
- Device description & intended use (variants, accessories)
- Classification & route (UK/EU differences noted)
- GSPRs / Essential Requirements matrix with evidence links
- Risk management summary (ISO 14971, top hazards/controls)
- Design documentation (inputs, key decisions, traceability seed)
- Verification & validation overview (what exists / what’s planned)
- Usability (IEC 62366) – formative summary, residual use risks
- Biocompatibility (ISO 10993) strategy & evidence table
- Software (IEC 62304) – only if applicable; otherwise excluded clearly
- Manufacturing & materials (as appropriate for stage)
- Labelling/UDI & IFU overview (traceable to claims)
- PMS/PMCF plan (proportionate, founder-friendly)
- Annexes & index: tidy links to data, reports and drawings
FAQs
Yes. We can build the full structure, write all summaries/matrices, and coordinate any missing evidence (bench tests, formative use, biocomp rationale, etc.).
Absolutely. We’ll inventory what’s there, map gaps, rewrite where needed, and link everything cleanly so the file is navigable and audit-ready.
Yes. We can scope and deliver the CER, or collaborate with your clinical partner if you already have one. The level of depth depends on your device/claims and timeline.
Your call. We can purely structure and write, or also plan/run small pieces of missing evidence (e.g., bench protocols, formative sessions) to close gaps.
Usually one core file with route notes for differences (UKCA vs MDR). We structure it so both reviewers can navigate smoothly.
You’ll get a simple upkeep guide (naming/versioning + “what to drop where”). If you prefer, we can provide a monthly slot to keep the file current as things evolve.
As standard, everything we create is owned by the client. We can work in your repositories/Drive if preferred.
