Services · EU MDR · Annex II / III · Annex XIV
Fixed-scope documentation engagements, in the order that de-risks them
Every engagement starts from evidence, not estimates: a fixed-price Gap Audit tells both of us exactly what your file needs. Then the writing engagements are quoted from findings.
01
Start here: the entry offer
Entry offer
Fixed scope · Fixed price
Technical File Gap Audit
Clause-by-clause review of your documentation against Annex II/III and your clinical evaluation against Annex XIV. Written gap report, prioritised remediation plan, 60-minute debrief — in 10 business days.
See scope & bookTurnaround10 business days
Price€ [X,XXX] fixed
OutputReport + plan + call
02
Writing engagements
Services
| Engagement | Scope | Turnaround | Basis |
|---|---|---|---|
| FlagshipCER Writing & Remediation → | CEP, state-of-the-art review, evidence appraisal, benefit-risk conclusions, cross-document consistency — to MEDDEV 2.7/1 Rev 4 and current MDCG guidance. | 6–10 weeks | Scoped after audit |
| FlagshipTechnical File Compilation → | Annex II/III documentation compiled, structured and written to submission-ready state — GSPR mapping, master index, full traceability. | 8–16 weeks | Scoped after audit |
| Post-Market Documentation Cycle → | PMS, PMCF, PSUR and SSCP updates as a structured annual cycle, feeding back into the CER. | Per cycle | Scoped |
| SSCP Writing → | Summary of Safety and Clinical Performance for Class III and implantable devices — HCP and patient sections, aligned with the CER. | 2–4 weeks | Scoped |
Received Notified Body questions on existing documentation? Structured NB response support is available for active review cycles.
Not sure which engagement you need?
That is what the Gap Audit is for — it tells both of us, in writing, before you commit to anything larger.