Built for ISO 13485, EU MDR, and 21 CFR Part 11
The eQMS your auditor was hoping you'd buy.
Reeve unifies documents, CAPAs, audits, vigilance, suppliers, training, and risk in one audit-ready platform - with 21 CFR Part 11 e-signatures and an immutable audit trail wired into every regulated step.
From $600/month · Onboarding included · Pre-launch pricing
One platform
Everything regulated manufacturers actually need
Reeve covers the whole quality system - not a slice of it. Each module talks to the others, so a non-conformance can spawn a CAPA, a CAPA can require a document update, and a document update can trigger training.
Documents & change
Controlled SOPs with versioning, distribution, e-signed approval, and change orders. Standards library tracks ISO, FDA, and MDR alignment.
Quality events
CAPAs with root-cause and effectiveness verification, non-conformances with disposition, and internal and supplier audits with sign-off.
People & competency
Employees, job roles (ISO §6.2 competency), training plans with quizzes, and external personnel with NDA/consent tracking.
Suppliers & purchasing
Approved supplier register, periodic re-evaluation with supplier self-scorecards, certificate uploads, purchased items, and customers.
Risk
ISO 14971 risk files with hazard library, structured Q&A, and e-signed release.
Platform & administration
Configurable approval workflows, role-based access with per-module permissions, invitations, and company profiles.
Compliance
Designed for the standards, not bolted onto them
Re-auth + e-signatures on every regulated transition, with immutable audit metadata and reason-for-change capture.
Document control, supplier evaluation, training records, internal audits, CAPAs, and risk - all mapped to ISO §§4-8.
Vigilance reporting (MIR for EUDAMED), FSCAs, FSN broadcast with delivery ledger, and PMS-feeding registration.
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