10 Tips for Optimizing Your Medical Device Quality Management System

April 18, 2024

In today’s market, medical device manufacturers should use a centralized quality management system to ensure their products are safe and effective. Whether it be more efficiently managing suppliers, better customer interactions or smoother regulatory compliance, an automated medical device quality management system (eQMS) can provide the boost your organization needs.

In this article, we explore ways to optimize your medical device quality management system with QMS software to improve efficiency, reduce costs and ensure compliance with regulatory standards.

What is a medical device quality management system?

A medical device quality management system is a formalized set of business processes that documents the policies and procedures a medical device company must use to ensure their products are safe and effective for the end user.

An eQMS is software designed specifically to digitize quality management system processes. eQMS software unites diverse applications and methods of managing your QMS into one, single source of truth. Which brings us to our first tip for optimizing your medical device quality management system – just do it.

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Implement Dedicated Medical Device QMS Software

The number one tip for optimizing a medical device quality management system is to automate the processes involved into one, dedicated and integrated software solution. A dedicated eQMS can drastically improve efficiency by centralizing all of your quality management process and providing a built-in framework for compliance where tasks are automated, data is available in real time and controls are easily managed.

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Take Advantage of Automated Document Control

Document control, easily the most utilized QMS application, is a prime example of where efficiencies can be gained through automation. Automated document control enables medical device companies to centrally store documentation within a cloud-based platform. This makes it easy for everyone within the organization to have access to consistent and up-to-date information.

An eQMS also enables users to automate approvals with FDA 21 CFR Part 11 electronic signatures. Automatic alerts trigger training sessions for specific individuals that are impacted when documents change. Document control automates traceability with timelines, and automates archiving processes. By always having the most up-to-date documentation, errors are more easily avoided, more impactful decisions can be made and documents are easier to share come audit time.

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Integrate Corrective and Preventive Action (CAPA) Processes

The CAPA process is data heavy, so automating corrective actions with an eQMS is an efficiency boon. Choose an eQMS that enables you to integrate digital CAPA management with other QMS applications, such as document control and reporting.

Integrating CAPA processes under one software system improves the time it takes to identify and resolve problems by providing insight into known product characteristics, nonconformances and the necessary steps toward resolution. CAPA data is automatically documented and stored, making it easy to pull data and reports for audit purposes or for trend analysis. This reduces audit time and audit findings and decreases the risk of product recalls, increasing safety and quality for consumers.

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Make the Most Of Supplier Relationships

Given recent supply chain problems, it is more important than ever to ensure good communication and record keeping for current and potential suppliers. Your eQMS should be able to streamline tedious supplier tasks with an easy-to-use supplier web portal that makes it easier to share information and attach files related to any supplier assigned items.

Use an eQMS supplier management application to efficiently automate workflows, assign tasks, nonconformance investigations and the completion of corrective actions, accordingly reducing the risk of poor quality. Centralize and streamline supplier documentation, allowing suppliers to easily locate documents and you to more easily demonstrate compliance and pull reports to determine future interactions.

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Manage Risk at All Stages

Medical device companies are expected to manage risk throughout a device’s lifecycle. Use your eQMS software to identify potential risks and develop methods to control those risks. Quality processes, such as design controls, calibrations, inspections and corrective actions, can be integrated so that data is shared.

Your eQMS is also a central repository for all of your risk documentation. It provides a built-in compliance framework, so that you’re always audit ready, with automatic traceability and tools for collaborating with and sharing data from customers and suppliers.

QT9 QMS is releasing a new Product Design Control module in summer of 2024 that will enable users to create templated or custom design and development plans that are automatically in sync with regulatory design controls. The module offers the ability to link with related quality tasks, such as document control, engineering changes, risk assessments and inspection plans, creating a line of sight between risk, quality and product goals.

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Use a Pre-Validated eQMS

A pre-validated eQMS can save you countless hours and thousands of dollars. A medical device company’s quality management system must be validated before use and periodically revalidated. Regulations with this requirement include ISO 13485:2016, FDA 21 CFR Parts 820 and Part 11, and EU GMP.

With a pre-validated eQMS like QT9, medical device companies don’t have to worry about getting the software they’re using validated by an outside provider or about doing it themselves. They can be sure their pre-validated eQMS offers the appropriate levels of security and functionality to minimize risk and enhance reliability and data integrity.

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Get Employees on Board

Medical device regulatory bodies call for companies to develop a culture of quality, with quality top of mind at every stage of a product’s lifecycle. But this mandate can remain elusive. Employees may be resistant to change and new demands on their time. New approaches may seem confusing if not effectively communicated by management.

Management can help employees keep quality top of mind by clearly conveying expectations and providing employees with the training and resources needed. An eQMS assists by providing centralized access to the most current documentation.

What’s more, most eQMS software solutions have employee training features that integrate with related quality applications. For instance when document changes are finalized in the eQMS, training can be automatically triggered for the employees impacted, helping to keep everyone on the same page and trained in a timely manner. In addition, management can use eQMS software to track training progress or create and assign additional training when needed.

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Stay on Top of Medical Device Regulatory Compliance Standards

Medical device companies are required to adhere to strict laws, regulations and standards. The International Organization for Standardization (ISO) has established standards that medical device companies must follow. ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

The Food and Drug Administration (FDA) has established current good manufacturing practice (GMP) requirements for medical device quality management systems in the USA. FDA 21 CFR Part 820 requirements, also known as Quality System Regulation (QSR) detail the requirements of the quality management system for medical device companies.

Starting on February 2, 2026, the U.S. FDA requirements for medical device quality management systems will more closely align with the international consensus standard for Quality Management Systems for medical devices (ISO 13485) used by many other regulatory authorities around the world. The revised FDA 21 CFR Part 820 requirements are called the Quality Management System Regulation (QMSR).

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Look for Scalability

If moving all of your quality processes to one solution seems daunting, look for an eQMS solution that offers the ability to grow at your own pace. While you’ll likely need document control from the start, other functions, such as automating supplier management, might be something that can wait a while.

An eQMS that enables you to implement different applications as able gives you and your staff the confidence to embrace new processes on your terms, creating smoother adoption.

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Try QT9 QMS Software

QT9’s eQMS offers more than 25 modules that come standard, including:

Document Control
Risk Management
Audit Management
Employee Training
Supplier Management
Customer Feedback
NEW Design Controls (Coming Summer 2024)

QT9 also offers the ability for medical device companies to create electronic Device History Records (eDHR) and Device Master Records (eDMR) with one click using QT9 QMS and QT9 ERP software. Take advantage of QT9’s free validation and a dedicated compliance portal for securely sharing DHR and DMR records with auditors.

Our highly rated eQMS is cost effective, easy to use and offers full customer support, an available ERP integration and Business Intelligence tool. QT9’s user-friendly interface and no-nonsense licensing lets medical device companies focus on getting quality, life-changing products to market faster.