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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Terumo logo
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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
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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 two levels of validation support and services that reduce the time and expense associated with validation.

Connected Quality

Eliminate data gaps in product quality

Improve end-product quality, speed new product introduction, make Smart Manufacturing a reality

Bridge the data gap between product quality control (QC) and in-process quality assurance (QA).

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

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Cloud-based SaaS

Access securely anytime and anywhere

Customer Complaint Management Software

The Hidden ROI of Customer Complaint Management

Businesses can only solve the problems they know about, which makes customer complaints an invaluable tool in managing risk. In regulated industries, complaints can be an early warning system that an organization may be at risk for regulatory action.

medical device quality manager working on product development Case Study

Case study


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

ETQ Reliance medical device quality management system for FDA regulation pre-clinical and clinical trials doctor with mask holding spine model Case Study

Case study


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.

Medical Device Case Study

Avanos Automates to Save $2 Million Annually

Learn how Avanos saved time and money by automating Audit Management, Calibration, DHF & Validation and more

See Case Study