Built for the people who actually own MDR readiness.
The manufacturer's regulatory team, the external consultant they hire, and the PRRC whose name is on the file — same evidence, same clause links, same audit trail.
For consultants
Deliver client-ready gap analyses in hours, not weeks.
RunaReg does the deterministic mapping. You provide the strategic judgment. Findings arrive clause-linked, exportable, and pre-formatted for client workshops — with your name on the cover.
Multi-client portfolio workspace with a per-engagement audit log
White-label PRRC exports and branded reports for client handoff
CER literature work that took 40 hours of searching and screening becomes a structured, methodology-logged pipeline
For manufacturers
Know where you stand, every day of the clock.
Upload your technical file. RunaReg surfaces every Annex II gap, drafts remediation text for your review, and tracks your deadlines so your regulatory lead always knows what to fix first.
One status view across every device family: readiness, gaps, next deadline
PSUR / CER / PMCF deadlines computed per device and market, with escalating alerts
Your evidence stays yours — exportable, SHA-256-hashed, with full provenance
For the PRRC
Prove you were there — and that you acted.
Under MDR Article 15, oversight responsibility is personal. RunaReg gives you a sign-off vault and a timestamped, append-only audit trail that documents your review at every gate.
Section-by-section sign-off with your role captured at signing time
ALCOA+ append-only audit log — including guidance-change acknowledgments
Submission readiness overrides require a stated reason, recorded permanently
In every role, the same boundary applies: RunaReg references, flags, and records. The qualified human decides.