Managed Compliance for Medical Device Development

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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

  • 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 Efficient Compliance

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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

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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

  • Risk analysis drives many design requirements
  • V&V testing depends on the release of many documents as well as hardware and software before it can begin
  • Software documentation gets special scrutiny and needs to be carefully integrated with overall product documentation
  • The 510(k) submission depends on completion of a broad set of DHF documents

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.

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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