- Why Us
A quality management system (QMS) and a product lifecycle management (PLM) system are closely related parts of the tech stack at many modern MedTech companies.
But because of their similarities and the wide variety of available solutions, there’s often some confusion about what these two systems do, how they interact, and how they can complement each other.
In this article, we’ll break down the two systems and illuminate how they work together—and what you should look for in each as you’re going through the buying process.
PLM and QMS software may have some overlapping functionality depending on the solutions you choose, but they are two distinct systems and it pays to understand the difference between them.
A company’s QMS is a formalized system that documents policies, procedures, documentation requirements, and processes that a MedTech company uses to ensure their products are safe and effective for the end user.
While organizations in many different industries use a QMS to manage the quality of their products or services, in MedTech a QMS is a regulatory requirement. Both the FDA’s Quality System Regulation (QSR) and ISO 13485:2016 provide instructions for what must be included in a MedTech company’s QMS.
The big question is how you will organize, manage, and maintain your QMS. It’s entirely possible (though highly discouraged) to do so on physical paper or by using generic software like Excel, Google Drive, or DropBox. However, most modern MedTech companies use a dedicated QMS solution that helps them ensure the quality and effectiveness of their devices and remain compliant with any and all regulations in their market.
Product Lifecycle Management software is used by MedTech companies to manage the entire lifecycle of their device(s)—from design and development to manufacturing, servicing, and obsolescence.
The PLM system acts as a central repository for any data or documents related to a MedTech company’s devices. Because a PLM system isn’t a regulatory requirement, different PLM solutions may look a little different from each other—but they’ll typically include features to help manage:
Bill of Materials (BOMs)
Even though a PLM system is not required, many MedTech companies will find it helpful to have one. This is especially true for companies with extensive product lines and global supply chains, but even smaller companies that manufacture complex devices with multi-layered assembly or a high variety of components can benefit from a PLM system.
It’s important to understand that a PLM and a QMS are not mutually exclusive. If you use QMS software, you might still benefit from having a PLM system in place. And the decision to use PLM software definitely doesn’t mean you no longer need a QMS solution.
In fact, the two systems are complementary and can work together to create efficiencies, improve compliance, and increase collaboration within your organization.
For instance, in the postmarket stage of the device lifecycle, MedTech companies are required to manage customer feedback, complaints, nonconformances, and CAPAs within their QMS. This data informs continuous product monitoring and enhancements, ensuring real-time improvements and up-to-date documentation while maintaining traceability between development and quality activities.
You might also keep supplier-related data like contracts or specifications within a PLM system while monitoring the quality of parts or components being supplied in your QMS (where your nonconformance process lives). Connecting supplier quality data to the PLM system can help you identify problems with specific suppliers and take action (like issuing a SCAR) faster and more efficiently.
If you’re evaluating a PLM and/or QMS solution for your company, you have three options to consider:
Software that was designed to be a PLM and also has a QMS package
Software that was designed to be a QMS and also has a PLM package
Purchasing separate QMS and PLM software solutions
As you consider these options, it’s important to remember that software is like any other tool—it’s designed to solve specific problems and deliver specific outcomes. Even though an “all-in-one tool” may sound great from an efficiency standpoint, it doesn’t necessarily mean that software will solve the problems or deliver the outcomes you need it to.
What you don’t want to do is choose a great PLM and then bundle it with a subpar QMS—or vice versa. That choice can jeopardize the overall efficacy of your company's operations by compromising on the individual strengths of each software.
As you look at QMS software, regulations and best practices in the MedTech industry should play a significant role in your decision. Your QMS software should help ensure compliance and align with standards like ISO 13485:2016 and ISO 14971:2019. This is what we call a purpose-built solution—one that’s specific to the MedTech industry and won’t require extensive work on your end to stay compliant.
There are a lot of QMS solutions out there that consider highly customizable software to be an asset, but in reality, customization means dramatically increased time to value and—because of the MedTech regulatory environment—the burden of validating any changes you make to the software.
As you evaluate your options, pay close attention to how quickly you’ll be able to onboard and implement a particular QMS solution and ask questions about what comes standard and what must be customized for the unique needs of the MedTech industry.
The choice of a PLM system is also an important one, and it will be similarly influenced by the MedTech industry and its regulations.
A good PLM system should support your compliance efforts and maintain traceability throughout the product lifecycle. It should connect to your QMS in order to share data between the two systems and ensure that data from design controls and risk management, for example, are not siloed in either system.
You should also assess the flexibility and scalability of any system you’re considering. How easy (or difficult) will it be to implement this PLM system in the first place? What would changing processes or workflows or expanding product lines require from your team? Can this system grow with you without growing out of control?
As you assess different PLM software, you’ll notice that many PLM solutions also come with an option for purchasing a QMS, too. This may seem like a good deal at first, but remember that the key here is to evaluate these solutions in isolation. As long as your QMS and PLM systems can connect with each other, you don’t gain anything by bundling an industry-agnostic QMS with your PLM.
In fact, QMS software that has to be heavily customized to meet your needs more than erases any efficiencies you gain by using the same provider for both PLM and QMS. At Greenlight Guru, we built our QMS software specifically for MedTech because we know this industry inside and out, and we know how difficult it can be to make a generic QMS solution work for MedTech companies.
Our connected QMS software, Greenlight Guru Quality, comes pre-validated per FDA and ISO best practices, so you can start on day one knowing that your QMS is aligned with 21 CFR Part 820, ISO 13485:2016, and ISO 14971:2019. And with Greenlight Guru Quality, your quality data is never siloed—you can connect to the PLM solution of your choice.
Ready to see what a purpose-built QMS solution can do for your business? Then get your free demo of Greenlight Guru Quality today →
Tory Lopez is a Senior Manager of Content Marketing at Greenlight Guru, the #1 provider of purpose-built MedTech solutions, with 5+ years of experience in the medical device industry and 10+ years in sales and marketing. Tory leads a dynamic team of writing and creative professionals, overseeing content strategy,...