Regulation (EU) 2017/745 — full life-cycle compliance.
Representative work
Device classes & artefacts we support.
Auto Injector combination ProductBalloon CatheterDiagnostic instrumentationBalloon Expandable Stent
The problem
Most of our clients' MDR technical documentation fail at the Notified Body level because the GSPR check list is too generic. Only one gap can create a nine month delay. "
Our solution
We provide Technical Documentation that addresses potential questions asked by auditors. Our documents follow Annex II/III structure and also address clinical evaluations as required by MEDDEV 2.7.1 rev 4. Additionally, all PMFs/PMCFs are addressed from day one.
Process
How we run this engagement.
MDR gap assessment vs MDD or current state
Technical Documentation update / authoring
Notified Body strategy & sample dossier prep
PMS, PMCF, PSUR system build
EUDAMED / UDI implementation
Regulation (EU) 2017/745 — full life-cycle compliance.
How we help
End-to-end EU MDR program management: gap assessment, Technical Documentation authoring, Notified Body selection and audit defence.
