About · Founder-led practice
The person behind the documents
Règle Santé is a specialist writing practice, not an agency. When you engage us, you engage one accountable specialist — supported by a documented, transparent process.
Founder
[PLACEHOLDER — founder name, biography and career history: to be supplied by the founder. Nothing on this site is fabricated; this section stays a placeholder until real credentials are provided.]
| Credential | Status |
|---|---|
| Regulatory / clinical background | [To be supplied] |
| Years in EU MDR documentation | [To be supplied] |
| Professional memberships | [To be supplied] |
| Redacted sample deliverable | [To be supplied] |
What we do — and what we do not
What we do
- EU MDR technical documentation (Annex II/III)
- Clinical Evaluation Reports and CEPs
- PMS, PMCF, PSUR and SSCP documentation
- Documentation gap audits
- Notified Body response writing (active review cycles)
What we do not do
- ☒Certification or CE marking decisions — we are not a Notified Body
- ☒QMS build-outs and ISO 13485 implementation
- ☒FDA submissions (510(k), PMA)
- ☒In-country representation (EC REP / PRRC roles)
- ☒Testing, clinical investigations, or lab services
Scope, plainly: Règle Santé is not a Notified Body and does not issue, grant or guarantee CE marking or certification. We prepare documentation. The manufacturer retains legal responsibility for conformity.
How this practice works
One writer, accountable
Every document is written by the founder — not passed to a pool of anonymous writers. The person you scope with is the person who writes.
Methodology before writing
Most Notified Body deficiencies are methodology failures, not evidence failures. Search strategies, appraisal criteria and evaluation plans come first.
Documents that hand over cleanly
Everything is delivered with traceability and rationale — so your team, your auditor, and your reviewer can follow every decision without us in the room.
Start with evidence, not a pitch.
The Technical File Gap Audit shows you exactly how we work — on your own documentation, at fixed cost.