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Medical Device Industry Guide to Selecting an EQMS Software

Top 10 most important capabilities an EQMS solution should have for medical device companies

Companies that develop and manufacture medical devices need electronic quality management system (EQMS) software that does much more than basic task automation. They need medical device QMS software solutions that enable them to make better decisions faster so they can get high-quality devices to market sooner.

If your company is looking to purchase or develop medical device QMS software, you can’t afford to overlook the 10 most important system capabilities listed below.

#1. Upholds Regulatory Medical Device Manufacturing Compliance

Your company’s medical devices affect consumers’ health and safety, which means you must have higher goals than simply maintaining adequate quality standards. Your products need to be continually guided by a medical device regulatory strategy that’s focused on maintaining quality compliance. Sustained compliance requires the use of tools that allow you to automate and connect your quality processes in alignment with relevant regulations and standards, such as ISO 13485, EU MDR, and 21 CFR Part 11. The medical device EQMS you choose to implement should also include extensive data protection and system security measures that meet applicable regulatory requirements.

#2. Facilitates Deep Connectivity

Unified data improves visibility and insights. When data and processes are united in a common cloud-based eQMS platform, there’s no need to build or purchase additional integrations to connect your disparate solutions. The deeper your data and process connectivity is, the better your organization will be able to compete in an evolving industry that is continually churning out innovative technologies. To keep pace, you need a medical device QMS software that provides the requisite scalability and flexibility.

#3. Provides End-to-End Quality Management Across the Medical Device Product Life Cycle

Maintaining quality consistency throughout the life cycles of your products is always an uphill battle if you’re using disconnected systems to manage different processes. An medical device eQMS that fully digitizes and harmonizes quality processes throughout the organization allows your medical device company to accelerate product life cycles while also dramatically reducing inefficiencies and the overall cost of quality.

#4. Expedites Medical Device Software Validation

Any digitized system used to manage quality data and processes must be validated in accordance with regulatory requirements. The eQMS market now offers cutting-edge medical device QMS software that features built-in medical device software validation accelerating tools. With a proven solution that incorporates risk-based validation tools, you can optimize efficiency without compromising compliance.

#5. Integrates With Manufacturing and Enterprise Business Systems

The value of your medical device eQMS is diminished if it can’t connect with and keep data synchronized between your existing enterprise, engineering, and process automation systems. A medical device eQMS that seamlessly connects quality and manufacturing processes on a single platform brings data and documentation together that is critical to both functions: electronic device history records (eDHRs), digitized work instructions, corrective action/preventive action (CAPA) documentation, standard operating procedures (SOPs), and so forth. Uniting this information within a single system also ensures procedural uniformity.

#6. Promotes Global Extensibility

A medical device eQMS capable of extending and reinforcing quality across your entire ecosystem will affirm that all sites and contractors maintain practices and documentation that are consistent with your organization’s overarching medical device regulatory strategy.

#7. Certified to and/or Compliant With Relevant Data Management Standards

Your medical device eQMS must guarantee the protection and privacy of data at rest, in transit, and in use. It should be certified to the standards and regulations that are applicable to your overall medical device regulatory strategy, such as HIPAA, ISO 9001:2015, and ISO 27001:2013.

#8. Provides Rapid ROI and Low Total Cost of Ownership

The true test of an eQMS solution’s value is how quickly it pays for itself and continues to generate a return on investment (ROI). If you choose to develop your own solution, you can only measure ROI based on the resources you devote to it. With commercially available software, you can refer to the provider’s customer case studies to approximate the potential returns and benefits. You can also calculate your estimated cost savings with this handy QMS ROI calculator.

#9. Minimizes IT Burden

Quality management is complex and resource intensive, but it shouldn’t be an extra burden on your IT infrastructure. Cloud-based software from a solution provider can give you access to the latest system features, security updates, and system integrations without the IT overload. That way your eQMS solution can be the responsibility of the individual designated to be the system’s administrator, not a headache for your IT department.

#10. Has a Proven Track Record of Customer Success

If you’re purchasing an EQMS from a provider, ensure that it is a reliable and comprehensive digital solution that’s trusted and recommended by medical device companies like your own. If the agencies that regulate your products have implemented a commercial EQMS for their own use, find out which solutions they use internally or those they trust when conducting audits of other medical device companies.

This list offers only a high-level understanding of the top factors your medical device company must consider before implementing a medical device eQMS. For a deeper look into the medical device QMS software capabilities that will help you reach your quality goals, check out MasterControl’s comprehensive QMS Buyer’s Guide.


James Jardine is the editor of the GxP Lifeline blog and the marketing content team manager at MasterControl, Inc., a leading provider of cloud-based quality, manufacturing, and compliance software solutions. He has covered life sciences, technology and regulatory matters for MasterControl and various industry publications since 2007. He has a bachelor’s degree in communications with an emphasis in journalism from the University of Utah. Prior to joining MasterControl, James held several senior communications, operations, and development positions. Working for more than a decade in the non-profit sector, he served as the Utah/Idaho director of communications for the American Cancer Society and as the Utah Food Bank’s grants and contracts manager.

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