Products
Quality Management That Doesn't Feel Like Paperwork.
Forget clunky legacy software. **Harmonizer** is the agile eQMS built for modern MedTech. Fully compliant with FDA QMSR and ISO 13485, yet simple enough to onboard in a day.
Validation Included
We come pre-validated for FDA Part 11. No expensive implementation projects—just log in and you are audit-ready.
Closed-Loop Quality
Connect the dots. A customer complaint automatically triggers a Risk Assessment update and opens a CAPA investigation in one flow.
Frictionless Signing
Integrated e-signatures that feel as simple as DocuSign, removing the bottleneck from your document control process.
FAQ
Q. 도입하는 데 얼마나 걸리나요?
A. With our pre-configured templates, go-live takes just 2 weeks.
Q. 기존 종이 문서는 어떻게 하나요?
A. We bulk upload and index your scanned legacy records.
Q. 밸리데이션 보고서를 주나요?
A. Yes, the full Validation Report package is included.