The workspace notified
bodies work in.
A dedicated environment where a designated notified body runs its own conformity assessment inside a manufacturer's live QMS — under recorded, revocable consent. You raise findings, sign your certificates, and manage surveillance, all in the same system the manufacturer and their experts already use.
MoniDoseQMS is a software platform, not a notified body or conformity assessment body. It does not perform, review, approve, or issue conformity assessments, certificates, or CE marking. Conformity assessment and certification are carried out solely by the designated notified body and the manufacturer, who hold all authority and responsibility for those decisions. MoniDoseQMS only provides the software that records their work.
What the workspace supports
Assessment to certificate, in one place
Everything a notified body needs to run an EU-MDR conformity assessment inside the manufacturer's own quality system — with the authority and every decision remaining yours.
Assess under consent
Enter a manufacturer's QMS through a time-boxed, read-only mirror. You only see what they grant, and every session is on a trail they can see. They can revoke access at any time.
Working papers & checklists
Walk an ISO 13485 clause checklist, request documents, and record structured review questions to the manufacturer — assembled into one printable audit report.
Raise findings
Log nonconformities with deadlines and escalation. A Major finding needs a verifier and blocks the certificate until it is resolved.
Sign your certificates
Issue with a 21 CFR Part 11 signing ceremony; Annex XII completeness is enforced at issue. You sign under your authority — MoniDoseQMS only records the decision.
Manage surveillance
The engine schedules the annual cycle, the recertification window, and the unannounced-audit quota — so nothing lapses unnoticed.
EUDAMED & public register
Track EUDAMED submission on an append-only history, and support public certificate verification against your register.
No standing access
You enter under the manufacturer's consent — and they can see everything
A notified body has no standing access to a manufacturer's QMS. You request what you need; they grant, narrow, decline, or counter-propose. Access is time-boxed, read-only, and fully logged — and they can revoke it at any moment.
Read-only mirror. You see the records, never change them.
Record-level consent. The manufacturer decides the exact scope.
Client-visible trail. Every page you open is on a trail they can see.
Impartiality, enforced
The independence rules aren't a policy page — they're enforced across assignment and the certificate signature.
- The certification decision-maker is never the person who assessed
- Only your own employees may hold a decision role
- Assessors must hold the scope code for the work (double-gated)
- A conflict-of-interest register blocks assignment prospectively
The third side of one ecosystem
MoniDoseQMS brings the manufacturer, the regulatory experts they hire, and the notified body that certifies them into one connected quality system — so the record a body assesses is the same record everyone else works in. See the ecosystem →
In development · testing
Are you a notified body? Help shape it.
The notified-body workspace is in active development. If you'd like an early walkthrough or to help shape it, we'd love to talk.