Medical Device Quality Management System

Never leave quality and safety to their own devices

In this highly regulated industry, where patient lives and brand value are on the line, an advanced medical device QMS offers compliance with regulatory standards such as Current Good Manufacturing Practices (GMP), 21 CFR Part 11 and Annex 11 and ISO: 13485, eMDR electronic form submission and more effective system validation.

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Safeguarding trusted brands around the world

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Nonconformance reporting

Turn yesterday’s mistakes into today’s accomplishments

Automate nonconformance management with an easy-to-use QMS system:  

  • Early detection of nonconformances
  • Perform root-cause analysis with advanced analytics
  • Maximize supply chain quality
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Supply chain management

Supply chains can be opaque but we help you see them clearly

Automated supply chain quality management helps you monitor and manage suppliers closely to:

  • Mitigate supply chain risk
  • Reduce the cost of poor quality
  • Improve customer experience

QMS Validation

Expedited validation with fewer disruptions

Validation for life sciences, pharmaceutical and medical devices companies is not an option. ETQ’s validation solutions make this mandatory process  fast, efficient and hassle-free. We offer three levels of validation support and services that reduce the time and expense associated with validation.

  • Self-validation: ETQ provides the ETQ Reliance Validation Execution Package that shows the development, testing and documentation approach for our platform and solutions.
  • ETQ Validation Toolkit: A comprehensive toolkit of procedural and validation templates that are a starting point for customers’ own validation of a configured ETQ Reliance solutions.
  • ETQ Validation Consulting Services: ETQ’s team of expert validation consultants will ensure compliance with current regulatory requirements and help you understand our vendor test records and methodology.

Why ETQ Reliance?

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40 easy-to-use applications

An Award-winning and streamlined user experience for all quality processes

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An agile platform

A mighty engine with the agility to adapt to your business, now and in the future

Cloud-based-saas

Cloud-based SaaS

Access securely anytime and anywhere

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Case study

Avanos

Learn how Avanos implemented an automated audit management system in preparation for Medical Device Single Audit Program (MDSAP) compliance

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Case study

DiscGenics

ETQ Reliance® provides quality management support for DiscGenics through pre-clinical and clinical trials into commercialization

Why not take a minute to find out more about ETQ Reliance®.