Comind.work is a complete quality management system for medical device companies. ISO 13485, EU MDR/IVDR, MDSAP, and FDA 21 CFR 820 compliant.
Document control. Design controls. CAPA. Training management. Audit management. All modules included.
You're tracking design history files in Excel, training records in a shared drive, and document approvals via email. It works - until the auditor asks for your audit trail.
This is how most device startups start. It's also why first audits fail.
Enterprise QMS platforms are built for 500-person device companies. They take 6 months to implement, cost $200K+/year, and require a dedicated admin team you don't have.
You need something between a spreadsheet and an enterprise platform.
Complete QMS
All included. No per-module upselling.
Version management, digital signatures, SOP and DHF lifecycle. 21 CFR Part 11 compliant.
Corrective and preventive actions with root cause analysis and effectiveness checks.
Training records, competency tracking, automatic assignment when documents change.
Change requests with impact assessment, approval routing, and implementation tracking.
Internal and external audit workflows, finding tracking, evidence collection.
Complaint intake, investigation, regulatory reporting workflows.
How it works
Not a sandbox. Your QMS, configured and live.
We learn your product, your stage, and your audit timeline. Map which modules you need now vs. later.
Week 1
Your document types, workflows, user roles, and approval chains configured in the system. Validation documentation included.
Weeks 2-3
Working QMS recording your quality activities. Your team trained. Ready for your auditor.
Day 21
Most pre-commercial companies need their QMS operational 3-6 months before their first audit. The sooner you start recording quality activities, the stronger your audit evidence.
Built to grow
Start with the QMS you need now. When your operations outgrow standard modules, the platform extends.
When you need a process your QMS doesn't have a template for, build it. Same system, same audit trail.
Run on your own infrastructure. Full data sovereignty for GxP environments. Unique among QMS challengers.
Built on a process automation platform refined since 2007. Not a startup experiment - production-hardened infrastructure.
Complete QMS - document control, CAPA, training, change control, audit management - configured in weeks.