Medical Device Case Study – Avanos Automates to Save $2 Million Annually

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Medical Device Quality Management Software (QMS) – ISO 13485

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.

Discover ETQ Reliance® Medical Device QMS
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Safeguarding trusted brands around the world

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Medical Device QMS

Speed to Market

Maintaining compliance while fostering innovation at the speed required to compete on a global scale requires streamlined, agile quality processes that quickly close the loop on medical device quality problems.

It’s why big players in the medical device industry recognize a critical need to implement an automated medical device quality management system, which provides a competitive edge through enhanced standardization and a best-practices framework for continuous improvement.

An advanced medical device QMS software offers compliance with regulatory requirements 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

Medical Device FDA Regulation
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Nonconformance reporting

Turn yesterday’s mistakes into today’s accomplishments

Automate nonconformance management with an easy-to-use QMS for medical devices:  

  • Early detection of nonconformances
  • Perform root-cause analysis with advanced analytics
  • Maximize supply chain quality
Learn more about Nonconformance Handling
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Supply chain management

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

Automated supply chain quality management with ETQ Reliance medical device QMS helps you monitor and manage suppliers closely to:

  • Mitigate supply chain risk
  • Reduce the cost of poor quality
  • Improve customer experience
Learn more about Supply Chain Management
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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 mandatory quality processes fast, efficient and hassle-free. We offer two levels of validation support and services that reduce the time and expense associated with validation.

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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).

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Benefits of a Medical Device QMS Software

Document Control

Collaboration

Proactively identifying problems

Supplier Management

Document control

A medical device without proper documentation is an accident (or audit) waiting to happen. An automated document control system can not only organize your documents so that you can find them when you need them; when you change a document tied to a particular product, they can also use automated workflows to make corresponding updates to any related documents.

workflow

Make collaboration easy

A QMS software for medical devices keeps track of everyone associated with a product — from the vendors who supply the raw materials to the folks who check quality on the plant floor. If there’s a nonconformance, a workflow automation can notify everyone involved that there’s all problem to solve and mitigate. It can get everyone in corrective action mode without wasting valuable time.

Closely integrating customer complaint management with other quality management software functions enables identification and analysis of suspected cause and process failures, informing the need for containment action.

Customer Complaints

Nonconformance

Minimize risk

As more and more medical devices are IoT-enabled, a medical device QMS software can monitor the information they generate and initiate proactive responses when there’s a nonconformance.

Med device supplier management

If a medical device company requires their suppliers to meet certain criteria, the ETQ Reliance QMS for medical devices can provide the platform for entering and updating information about the vendor’s own quality management.

  • Foster better communication and visibility with suppliers
  • Increases visibility on both sides and track items that need to be addressed
  • Improve responsiveness of suppliers, while also streamlining collaboration at every phase of the process
Document Control

Document control

A medical device without proper documentation is an accident (or audit) waiting to happen. An automated document control system can not only organize your documents so that you can find them when you need them; when you change a document tied to a particular product, they can also use automated workflows to make corresponding updates to any related documents.

Collaboration

workflow

Make collaboration easy

A QMS software for medical devices keeps track of everyone associated with a product — from the vendors who supply the raw materials to the folks who check quality on the plant floor. If there’s a nonconformance, a workflow automation can notify everyone involved that there’s all problem to solve and mitigate. It can get everyone in corrective action mode without wasting valuable time.

Closely integrating customer complaint management with other quality management software functions enables identification and analysis of suspected cause and process failures, informing the need for containment action.

Customer Complaints
Proactively identifying problems

Nonconformance

Minimize risk

As more and more medical devices are IoT-enabled, a medical device QMS software can monitor the information they generate and initiate proactive responses when there’s a nonconformance.

Supplier Management

Med device supplier management

If a medical device company requires their suppliers to meet certain criteria, the ETQ Reliance QMS for medical devices can provide the platform for entering and updating information about the vendor’s own quality management.

  • Foster better communication and visibility with suppliers
  • Increases visibility on both sides and track items that need to be addressed
  • Improve responsiveness of suppliers, while also streamlining collaboration at every phase of the process

Our mission is to deliver optimal quality that creates benefits for top- and bottom-line financials and global growth. ETQ Reliance medical device QMS gives customer the power to:

Improve Decision Velocity

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Improve decision velocity by delivering trusted prescriptive and predictive information using analytics, automation, and AI

Improve decision velocity

Drive Compliance at Scale

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Efficiently meet changing regulatory, compliance, customer, and market requirements at scale

Drive compliance at scale

Improve Supplier Quality

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Improve supplier quality to ensure positive business impact and enhanced customer loyalty

Improve supplier quality

Reduce Cost of Quality

reduce cost of poor quality

Reduce cost of quality to minimize business disruption, brand risk, and revenue impact

Reduce cost of quality

Accelerate time to market

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Accelerate time to market by optimizing the product life cycle

Accelerate time to market

ETQ Reliance QMS

ETQ Reliance QMS

A quality management solution (QMS) that delivers measurable business value

Product overview

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.

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Case study

Avanos

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

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Case study

DiscGenics

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

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ETQ QMS Surgeon Mask Operating Room CASE STUDY

Case Study

Symmetry Surgical Uses ETQ Reliance Out-of-the-Box

Like many life sciences and medical device companies, Symmetry Surgical faced several challenges. The company needed to adhere to changing FDA and other regulations while simultaneously protecting its brand value.

But as a small company comprised of four operations sites, 250 employees, and just six quality engineers, it was clear that Symmetry needed a medical device quality management solution that would provide immediate value and was able to grow as the company’s needs evolved.

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