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What’s your favorite regulatory pitfall?
I know it’s a strange question, but if you’ve spent much time in the medical device industry, there’s likely a few that come to mind. People reach out to me all the time asking how to break into the medical device industry—and I love those conversations. But here’s what I tell them:
This industry is not for the faint of heart.
Most folks start out energized and motivated to save lives and bring something meaningful to market. But it doesn’t take long for regulatory hurdles to get in the way—and that’s where a lot of good ideas stall out.
After working with dozens of startups, I’ve seen the same five mistakes trip up product teams again and again. These aren’t just small oversights—they’re pitfalls that derail timelines, drain budgets, and exhaust entire teams.
Let’s walk through each one—and how to avoid them.
1. Skipping the Design History File (DHF)
The DHF isn’t just a document you fill out at the end of a project. It’s a map. One that guides your product development journey, supports your submission, and stands up under audit.
I’ll admit it: I was once that project manager who gave myself a few weeks at the end of a schedule to “compile the DHF.” In reality, the compilation should be done in parallel with the documents that are being produced.
The fix: Build your DHF as you go. Ensure traceability from user needs to design validation. That traceability is what makes the DHF a valuable, navigable document instead of a painful afterthought.
2. Underestimating risk management
If you're working in the medical device industry, you should be familiar with ISO 14971. And if your product development engineers don’t know what those numbers mean, it’s worth taking the time to teach them.
Risk management isn’t just for the safety team—it’s central to how you design your product. And regulators will expect to see documented evidence of a structured process.
The fix: Start early. Document thoroughly. Connect risk controls back to your design inputs and outputs. Make risk management part of your product culture.
3. Forgetting post-market surveillance (PMS)
It’s easy to assume regulators are only concerned with what happens before a product hits the market. But that couldn’t be further from the truth.
Post-market surveillance (PMS) is critical. It’s how you demonstrate ongoing safety and effectiveness. And it’s your best defense against product liability claims.
The fix: Treat PMS as part of your core regulatory strategy from day one. Don’t wait until your product is on shelves. Set up a feedback loop that actively collects, reviews, and responds to real-world data.
4. Treating usability as an afterthought
Usability isn’t just for big companies with big budgets. In fact, it can make or break a device—especially in high-risk or high-stress use environments.
Poor usability leads to user errors. And user errors are risks. See above.
The fix: Start with standards like IEC 62366-1, and make usability part of your development process. Keep users involved through iterative testing and design refinement. And if you haven't read The Design of Everyday Things, now's a good time.
5. Relying too heavily on predicates
The 510(k) pathway is attractive. It’s familiar. It feels fast. But it’s not always the right choice—and it’s not always faster in the long run.
Sometimes, a De Novo or even a PMA pathway might serve you better. And yes, that Class III “moat” might even give you a strategic edge.
The fix: Let your product guide your regulatory strategy—not the other way around. Evaluate all your options and choose the one that best aligns with your device, your market, and your long-term goals.
The bottom line
Success in this industry doesn’t come from cutting corners—it comes from knowing which obstacles to avoid, which to face head-on, and which to reframe as opportunities.
If you can steer clear of these common pitfalls, you’ll save your team time, money, and a lot of unnecessary frustration.
And if you’re looking for a partner to help you navigate these challenges, Greenlight Guru is built for exactly that. From design controls and risk management to PMS and audit readiness, our platform helps medical device teams move fast—without sacrificing quality or compliance.
Ready to sidestep the pitfalls? Learn how Greenlight Guru can support your team.
At Greenlight Guru, we know and understand the regulatory pitfalls medical device companies face because our software solutions were built by and for medical device professionals. We took hundreds of years of collective industry knowledge and used it to build QMS software that simplifies documentation and compliance to help you focus on what matters most.
With Greenlight Guru, you’ll have a design controls workspace that allows you to maintain traceability through an iterative design process and automatically generates and updates your DHF. You’ll also be able to bring the team together to document and approve design reviews with full visibility of your design matrices. And it all happens in software that’s validated per FDA and EU regulations, as well as standards like ISO 13485:2016 and ISO 14971:2019.
Ready to see what an intuitive, purpose-built QMS can do for your business? Then get your free demo of Greenlight Guru today!
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