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Why would you need a Digital QMS?

In the world of medical device development, there are two essential pillars that every team must master in order to bring their Medical Devices to market: the Technical File (TF) and the Quality Management System (QMS). Although they may seem tedious and unnecessary, they are the key to success in a hyper-competitive and regulated market. See here an example of an ambitious company that tried to do without it: Bouthaina's story.

The Technical File

The Technical File is usually written by engineers, who meticulously document every aspect of the product's design, production cycle and post-market surveillance - from specifications to materials to intended use. On the other hand, the QMS is the responsibility of the Quality Assurance team, who ensure the product is designed, developed and tested in accordance with the relevant regulations and standards.

Despite the clear distance between these two teams, they are in fact interdependent. The secret to the success of these two elements is exhaustive traceability - we need to be able to trace every stage in the device's life cycle, from design to post-market surveillance. And it needs to be proven that all these activities are done following a laid out plan which was derived from  requirements of the organization, the market, and legal directives and standards. However, it can be a lot of unpleasant work if you haven't got the right tools at hand: Arnaud's Story.

Traceability in the product lifecycle

Traceability is crucial since it allows teams to demonstrate that they control every aspect of their Medical Device. It also shows that they have taken the time to carefully plan and document each stage of the process, and that they are committed to continuous improvement. It also allows teams to link procedures to work instructions and templates, ensuring that every aspect of the medical device is documented regularly. This allows teams to quickly and effectively report any issues, whether complaints or other feedback.

Imagine you're part of a brilliant team of engineers developing a cutting-edge Medical Device with the potential to save many lives. You've put in long hours, overcome many challenges and your product is ready to go to market.

Wait - there's one crucial element missing: a system to ensure that all product-related documentation is properly organized and tracked. That's where an electronic quality management system (eQMS) comes in. Not only does this make document management easier, it also ensures that all processes are properly managed.

At Matrix Requirements, we go one step further and integrate both an eQMS and an ALM system into a single platform. This allows users to create and manage their quality management system and link it directly to their product information. The aim is to enable teams to collaborate, including R&D and quality assurance teams, and to store all information in a single platform from which the appropriate documentation can be extracted.

By using our platform, companies can save time, reduce the risk of compliance gaps and bring innovative medical devices to market more efficiently than ever before. At Matrix Requirements, we're committed to helping companies succeed, and our integrated platform is just one way we're doing that. And, the best, this system is a result of experience from real life in medical device companies: Ann's story.

About the Author
Regina Preysing
Partnerships Manager