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

  • Efficiently manage complex product information.
  • Collaborate and enable rapid design changes.

Built-In Compliance

  • Generates rigorously controlled DHF documents.
  • Collaboration platform configured around medical device regulations.
  • Extensive support for risk management and V&V testing.

Pre-configured Cloud Software

  • Flat fee subscription.
  • Compliant and secure.

ZipQuality Features

Up and Running in Days

  • Pre-configured system(processes and tools); no need to alter your quality system.

Stay Up-to-Date and Audit-Ready

  • Integrated system easily handles rapid design iterations for product documentation.

Minimize Distraction During Development

  • Experienced consultants guide your team at every step.

Grows with your Company and your Products

  • Fully-featured, scalable software tools built on the proven, powerful ENOVIA platform.

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

  • Product development plan
  • Risk management plan / report
  • Risk analysis (System Hazard Analysis, Design FMEA, Use FMEA, Process FMEA)
  • Product requirements, hardware requirements, software requirements
  • Product design docs (mechanical , electrical, software, UI/ID)
  • Design V&V testing (test plans, protocols, reports, trace matrix)
  • Change controls
  • Design reviews
  • Design transfer to manufacturing documents
  • Labeling and packaging documents

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



ZipQuality Datasheet

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Agile Development Blog

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ZipQuality, what does it do?

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Medical Device,
Documentation Map

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