About
Specialist EU MDR Clinical Documentation Writing.
Règle Santé is a specialist regulatory writing consultancy focused on EU MDR clinical evaluation, post-market documentation, and Notified Body response work for medical device teams.
What We Do — and What We Do Not
We focus exclusively on EU MDR clinical and post-market regulatory writing. That means CERs, PMS documentation, PMCF plans, PSURs, SSCPs, and Notified Body response packages.
We do not position ourselves as a broad regulatory writing firm covering QMS documentation, FDA submissions, IFU, or labelling. Our narrow focus means the quality and depth of what we do is consistent across every engagement.
Specialist focus
We concentrate on EU MDR clinical evaluation and post-market documentation. This focus means every engagement benefits from deep, current knowledge of CER, PMS, PMCF, PSUR, and SSCP requirements.
Writing as a discipline
Regulatory writing is a skill distinct from regulatory knowledge. We combine both — so the documents we produce are not just technically accurate, but clear, structured, and review-ready.
Remote and flexible
We work with medical device teams remotely across Europe, the UK, and global markets. Our workflow is built for distributed collaboration with your RA/QA, clinical, and technical teams.
Our Approach
Clear, Evidence-Based, Reviewer-Friendly Writing
Clinical evidence first
We start by understanding the clinical evidence, residual risks, claims, intended purpose, and post-market data before drafting conclusions. Writing comes after understanding.
Lifecycle alignment
We connect CER, PMS, PMCF, PSUR, SSCP, and risk documentation so the clinical evidence story remains consistent across the technical file and across review cycles.
Clear regulatory narrative
We write for regulatory reviewers, internal RA/QA teams, clinical stakeholders, and decision-makers. Clarity and traceability are not optional — they are the standard.
Who We Help
We support medical device manufacturers, RA/QA leaders, clinical affairs teams, and regulatory consultants who need focused writing capacity for EU MDR clinical and post-market documentation.
Device teams
Small and mid-sized medical device manufacturers building or maintaining EU MDR technical files.
RA/QA leaders
Teams preparing for MDR reviews, surveillance audits, or managing Notified Body correspondence.
Clinical affairs
Teams responsible for CER updates, PMCF execution, and post-market clinical follow-up.
Consultants
Independent regulatory consultants who need specialist EU MDR clinical writing capacity.