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.
Faster Time To Market
On Demand Services Enabled by Software
A Better System for Distributed Cross-Functional Teams
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
Medical Device Documentation Map