Document control, design controls, CAPAs, and supplier management — designed to support compliance with ISO 13485 and 21 CFR Part 820. Sign up and start working in minutes.
Your document control lives in a validated SharePoint nightmare that takes 15 clicks to approve a single SOP.
Design history files are scattered across shared drives, and nobody can find the right version of the risk analysis.
Your CAPA process involves emailing Word docs back and forth and hoping Track Changes didn't break.
You're paying six figures for a QMS that requires a consultant just to configure a new form.
Audit prep means two weeks of scrambling to find records your auditor will ask for in the first five minutes.
Not adapted from generic project management. Purpose-built for regulated products.
Link user needs → design inputs → design outputs → verification → validation. Trace any requirement to its test result in seconds.
Version control, approval workflows, and 21 CFR Part 11-aligned electronic signatures. Generate watermarked controlled copies on demand.
Maintain your risk management file alongside design and production records. Trace hazards to mitigations to verification evidence — all linked.
Configurable templates for CAPAs, NCRs, complaints, and MDR reporting. Root cause tools built in. Effectiveness checks scheduled automatically.
Onboard, qualify, and re-evaluate suppliers with risk-based workflows. Maintain your ASL without a spreadsheet.
ISO 13485 compliance pack with 30+ templates. Immutable audit trail for every record. Stop prepping for audits — just be ready.
Sign up in 30 seconds. No credit card. No sales call. No consultant required.
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