The quality systems most medtech teams are stuck with aren’t built for how they work today. 21 CFR Part 820 was authorized by the Federal Food, Drug, and Cosmetic Act of 1978, long before the software industry even existed. And while the regulations themselves aren’t going anywhere, the world they were built for has changed dramatically.
The medical device industry came late to the software revolution, partly due to a culture that shunned the “move fast and break things” ethos of early tech companies, and partly due to a regulatory framework that has always seemed more aligned with waterfall project management than agile.
But medtech is going through a generational change right now. The industry may have been late to the software revolution, but now it’s at the center of it. Software in medical devices (SiMD) and software as a medical device (SaMD) are some of the fastest growing verticals in the medical device industry, and there are more software developers working in medtech than ever before.
That’s not only changing how medtech companies design, develop, and manufacture their products, it’s also changing how they meet regulatory requirements as they do so. The influx of software developers and agile project management has created a massive demand for faster, more flexible tools. Many medical device companies are still relying on bloated enterprise QMS software or risky spreadsheet-based quality systems, but neither of those options is built for the new reality of medtech.
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There are more tools than ever available to help medical device companies speed up development. New technology like 3D scanning and AI analysis, combined with even more options for outsourcing, mean that teams working on both software and hardware devices are able to develop faster.
One glaring exception to this boom in innovation, however, has been the QMS industry. Whether they’re working on hardware or software, no engineer wants to spend time on tedious documentation. But the influx of software engineers into medtech has highlighted the fact that many QMS solutions are still built primarily for Quality teams. In fact, 59% of respondents in our 2025 State of the Medical Device Industry Report told us they were still using paper or general-purpose tools for product development.
The result? Compliance becomes a side process. Product teams avoid the QMS. Quality teams are left scrambling to catch up. And audit-readiness becomes a fire drill, not a constant state.
Even in companies working on hardware products, Product teams dislike working in rigid QMS software. Product engineers lose valuable time and may even work outside the system, risking audit-readiness. For software products, it’s even worse. Developers have their own tools they’re used to working with, and they expect compliance to happen in the background via deep integrations with QMS software.
Unfortunately, most teams are forced to choose between traditional QMS solutions that require heavy customization just to be compliant with medtech regulations or spreadsheets that are slow, manual, and massive compliance risks. Companies are beginning to realize that these older tools can’t be retrofitted to the new environment. They need solutions that can keep up with the pace of change in medtech.
The good news is, the pace of change in medtech is driving innovation throughout the industry. And while some QMS providers have been slow to adapt, there is a generational change brewing in the QMS industry.
As teams grow less tolerant of top-down, documentation-heavy systems, QMS software is becoming lighter and more flexible, using integrations and adaptable processes to let teams develop quickly using project management methods like agile. These new solutions prioritize the needs of Product and automate as much of the documentation and quality workflows as possible, making it easier for small, Product-led teams to develop quickly while staying compliant.
Regulatory agencies like the FDA have also taken note of the changes happening in medtech. 21 CFR Part 820 may not be going anywhere, but it is being harmonized with ISO 13485:2016, a long-awaited change that will streamline compliance requirements for many businesses. There have also been a flurry of guidance documents related to software-enabled devices, and AAMI TIR45:2023, Guidance on the use of agile practices in the development of medical device software, is now an FDA-recognized consensus standard.
You don’t have to look very hard to see these changes affecting the entire industry. The FDA’s first pre-determined change control plan (PCCP) guidance, for instance, was aimed at manufacturers using machine learning algorithms in their medical devices. However, once the agency realized the broad utility of a PCCP, they released a general-purpose PCCP draft guidance for all medical device manufacturers.
This is not the last time we’ll see software drive changes broadly across medtech. And it’s not the last time we’ll see regulators adapting to conditions on the ground with new guidance and perspectives. What’s needed now is a new class of quality management systems - one that works in the background, integrates seamlessly, and gives teams compliance without compromise. A system that aligns with agile development instead of fighting against it.
We can think of the move toward a more product-centric QMS as a move toward more autonomy for Product Development teams. They can work faster, stay compliant, and rely less on a large QA team to keep the system up to date.
That level of autonomy will continue increasing as AI is integrated into QMS solutions. The industry is already moving in that direction, and AI is set to take on more of the manual, repetitive work that drives up headcount as companies grow. AI shouldn’t replace your QA team - it should make them exponentially more effective. The future of AI in QMS isn’t automation for automation’s sake. Rather, it’s giving Quality more respect and autonomy by reducing the busywork and policing, so your entire team can focus on building safer, more effective products.
Practical applications of AI within a QMS will include things like:
As AI transitions from a helper within the system to an agent, it will also end up summarizing changes, generating trace matrices, and drafting documentation. And that’s what seems feasible right now. Each new step is going to open up more possibilities for innovation.
Remember, mere compliance doesn’t create a safe and effective medical device. Medtech companies will absolutely need to stay focused on quality, but the best way to help them do that is by eliminating the friction with their quality systems. By making compliance as simple as possible, the next generation of QMS solutions will allow teams to go beyond mere compliance and focus on building the safest, most effective devices for the patients who rely on them. The next wave of medtech won’t be built on legacy systems. It’s time for quality to move at the speed of innovation.
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Early-stage medtech teams need a QMS that lets Product teams focus on development while compliance builds in the background.
With Ultralight by Greenlight Guru, you’ll have a flexible, lightweight QMS that empowers Product teams to work at the speed they're used to without getting bogged down in documentation. Ultralight is designed to get out of your team's way, integrating with the tools you already use and flexing to your processes. You'll have everything you need to stay compliant while moving faster toward submission.