QMS setup.
Implementation of a Quality Management System aligned to ISO 13485, ICH Q10, 21 CFR 820, or QMSR — with explicit attention to where the standards converge and where they still diverge.
The fit.
MedTech companies preparing for QMSR transition. CROs responding to sponsor RFPs that specify ICH Q10 alignment. Combination-product founders pre-MAA.
What this delivers.
QMS framework, SOP set, document control, training records, first audit-ready state aligned to declared regulatory regime.
Where the edge is.
Vendor-neutral — not tied to a specific QMS-software stack. QMSR-MDR convergence work credible from inside Class III device manufacturing exposure. Multi-jurisdiction depth (US, EU, India) when assets touch more than one regulator.
The shape of the work.
Every engagement is scoped per situation. The shape — focused diagnostic, structured implementation, ongoing partnership — emerges from the discovery conversation rather than a fixed package. Some engagements are short and intense; some are months-long structural builds; some are recurring quality oversight. We talk first, then scope.
Discovery.
Confirm regulatory regime (ISO 13485 / Q10 / 21 CFR 820 / QMSR / multi).
Scoping.
Proposal aligned to phase-of-business (early-stage, MAA-prep, post-launch).
Setup.
Framework, SOPs, controls, training, audit-readiness across the declared regime.
Handover.
QMS live, documentation complete, optional ongoing maintenance arrangement.