Quality Management System for Medical Devices

ETQ Reliance

QMS software designed to ensure product quality, compliance and brand reputation.

Pressure is rising globally for medical device manufacturers to increase quality, a trend that’s led to sweeping changes to laws and standards in recent years. Manufacturers must guarantee their products meet the highest standards of safety and compliance, with the knowledge that patient lives and brand value are on the line. Automated quality management systems help organizations identify, respond to and report on product issues, enabling them to prevent quality failures and protect patients.

A focus on quality creates audit-ready compliance

  • Minimize risk to brand reputation
  • Increase quality and profitability
  • Improve customer experience and support
  • Reduce defects and customer complaints
  • Prevent or minimize product failures and recalls
  • Reduce the cost of quality
  • Manage supplier quality issues
  • Increase speed of new product introduction (NPI)
  • Measure and improve perfect order rate
  • Identify and mitigate supply chain risks
  • Centralize documentation and training records
  • eMDR Electronic Form Submission

ETQ SaaS and Trust
ETQ Reliance is a (SaaS) application that offers customers a fully managed software solution that vastly reduces the technology footprint required for QMS software, and delivers an always-on, always-updated, redundant and secure software environment that scales with customers' needs.

Integrated Data

Siloed data blocks accurate reporting and insight-driven action. Improve consistency and performance across widely distributed facilities with centralized reporting.


Supply Chain Quality

Poor visibility and control over extended supply chains increases risk of unknown raw materials and process changes, leading to quality failures and complaints. Integrate your supply chain more tightly with automated supplier quality management.



Manage complaint investigation, compliance tracking and regulatory reporting in a unified, collaborative environment. Meet 21 CFR Part 11, 21 CFR Part 820 and GMP guidelines, as well as ISO 9001, ISO 13485, ISO 45001 and ISO 14001.


Blog Posts

ISO Certification: Why Life Sciences Companies Should Be Aware Of Its Benefits

We all know that implementing a management system or operational excellence program into a life science company’s workflow isn’t without its costs.

How To Map Your QMS To EU MDR Requirements

Medical device manufacturers who are not up to speed with the latest European Union compliance requirements could find themselves struggling to catch up.

Webinar: How To Prepare For FDA Migration To ISO 13485 And MDSAP

Media theorist Marshall McLuhan may not have had quality management for medical devices in mind when he coined the phrase “global village” in the 1960’s, but the fundamental interconnectedness of modern society has brought his concept to life.