An agile development platform for medical devices

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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

  • Less time editing documents, more time on design and test.
  • No documentation surprises and delays.
  • Quality experts to assist your team at every step.
  • Documentation up-to-date and audit ready.

On Demand Services Enabled by Software

  • One flat fee subscription.
  • No software cost.
  • Hosted, compliant, secure

A Better System for Distributed Cross-Functional Teams

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  • ZipQuality consultants work closely with your product development team to manage the compilation and updating of all of your DHF documentation.
  • We use a suite of hosted software tools built on the proven, powerful ENOVIA platform. 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 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.
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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

Medical Device Documentation Map

Resources

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Aaron’s Video

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ZipQuality Datasheet

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Agile Development Blog

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ZipQuality, what does it do?

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