Medflow QMS is the electronic quality management system where your controlled records live — document control, CAPA, supplier management, training, and change control, with e-signatures and a full audit trail. The system of record an auditor expects to see.
Quality records scattered across drives, email threads, and spreadsheets can't show control, can't prove traceability, and can't survive an audit. As you head toward ISO 13485 and your first CE mark or FDA submission, "the documents are somewhere" isn't a quality system — it's a liability with a deadline.
Everything a medical-device quality system has to hold — kept controlled, versioned, and traceable, so that when an auditor asks, the answer is one click, not one week.
Versioned, reviewed, e-signed, effective-dated — always the right version in the right hands.
Issues captured, investigated, and closed out — with the full trail intact.
Approved suppliers, agreements, and monitoring in one controlled place.
Who's trained on what, and when it's due again — evidenced, not remembered.
Changes proposed, reviewed, and released under control — nothing slips through.
Every approval e-signed; every action recorded in a complete, tamper-evident trail.
Most eQMS store your documents as files in folders. Medflow QMS maps your product's roadmap — every activity, its dependencies, owners, and templates — into one connected graph, so each document lives in the context of everything it depends on. Open one and you see why it says what it says, not just what it says.
Each document is linked to the requirements it satisfies, the standards it's written against, and the records it depends on — visible as you read and write.
Because the connections are on the surface, a new hire or a colleague from outside regulatory can follow a document. Onboarding is faster, and knowledge doesn't walk out the door when a person does.
Because the graph knows how documents connect, an agent can draft each one in context — with a person reviewing and approving every document. Semi-automation, human in the loop by design.
Versioned documents, e-signed approvals, and a full audit trail — so control is something you can demonstrate on the spot.
Designed around ISO 13485 quality processes and 21 CFR Part 11-style electronic records and signatures. (Built for these workflows — not a certification of your company.)
The finished, controlled records land here, and your issue management runs here — one place, under control.
No software makes you ISO 13485 certified — and Medflow QMS won't claim to. What it gives you is the controlled system of record and the audit trail a 13485 audit expects, so your certification work rests on something solid instead of a folder of PDFs.
The controlled system of record for medical-device quality — where every document explains itself, e-signed and audit-trailed.
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