An agile development platform for medical devices
ZipQuality is a software enabled service that assists medical device companies in bringing new products to market. Our collaboration platform manages rapid design changes for agile teams while ensuring regulatory compliance.
A Better System for Distributed Cross-Functional Teams
Faster Time To Market
Pre-configured Cloud Software
Up and Running in Days
Stay Up-to-Date and Audit-Ready
Minimize Distraction During Development
Grows with your Company and your Products
ZipQuality Service Overview
ZipQuality Service Provides – Management of Design Controls and DHF Documentation
Efficient and rigorous compliance with FDA QSR (21 CFR 820), IEC 62304, ISO 14971, IEC 62366, EN 60601-1, and related standards for medical device development.
We understand complex, software-intensive medical devices. The ZipQuality system is based on a structured documentation framework that supports good systems engineering, efficient risk management, and clear traceability