Managed Compliance for Medical Device Development
ZipQuality is a quality engineering service that assists medical device companies in bringing new products to market. We offer efficient compliance based on streamlined quality processes supported by a suite of hosted software tools.
Faster Time To Market
On Demand Services Enabled by Software
A Better System for Efficient Compliance
ZipQuality Service Overview
Our integrated system enables rapid design changes while keeping product documentation and data in sync
and maintaining all the records in an audit-ready state.
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
Compiling all of the DHF documentation for a new medical device can be confusing, even for experienced engineers. That’s why I created this “map” of document interdependencies. It’s a way to help explain graphically how the many documents fit together for a new product. Some key points in the map are
This Documentation Map is based on a hypothetical medical device with hardware and software components, including sterile disposable components (i.e. a Class II interventional device with embedded software). The exact set of documents needed will vary across medical devices and quality systems, but will likely follow the outlines of this map if the device includes software.