ISO 13485 · ISO 9001 · ISO 27001 · EU MDR · 21 CFR Part 11
The ReeveHQ eQMS
An ISO 13485 eQMS for medical devices - and the quality system behind every other standard you certify to.
One platform
The jobs your quality system will do for you
Reeve covers the whole quality system - not a slice of it. Each module talks to the others, so a non-conformance can raise a CAPA, a CAPA can require a document update, and a document update can trigger training.
Keep every document controlled
Versioned SOPs with distribution, e-signed approval, and change orders on every revision. The standards library keeps ISO, FDA, and MDR clauses tied to the documents that satisfy them.
Close quality events without chasing people
Non-conformances with disposition, CAPAs with root-cause and effectiveness verification, and internal and supplier audits with sign-off - each one able to raise the next.
Prove who approved what, and when
Configurable approval workflows, Part 11 e-signatures with reason-for-change, and an immutable audit trail behind every regulated step. Access is granted per module, per person.
Keep suppliers qualified and evidenced
Approved supplier register with periodic re-evaluation, supplier self-scorecards, certificate uploads, purchase orders, and incoming inspection records.
Hold risk where an auditor can find it
ISO 14971 risk files with a hazard library, structured Q&A, and e-signed release.
Show your people are competent
Employees, job roles carrying ISO §6.2 competency, training plans with quizzes, and external personnel with NDA and consent tracking.
39 modules, built - not a roadmap.
The system
Every module, on one screen
Not a mock-up of a future release - the shipped interface, shown with sample data.
Start today for $50. Take 30 days to decide.
One verification charge opens your full workspace - every module, your own quality system, from day one. Continue after 30 days and the $50 comes off your first payment; your price is agreed with us directly. Nothing renews by itself.