The MedTech Quality Naughty & Nice List

What Santa (and the FDA) Want You to Know This Holiday Season

The holidays are a time for reflection—on what we’ve built, what we’ve neglected, and what we promise to do better in the year ahead. For MedTech startups, this season is a perfect moment to take a lighthearted (but honest) look at your Quality and Regulatory behaviors. Because while Santa may be the one checking lists twice, the FDA, your Notified Body, and your investors are checking all year long.

To help you ring in a more compliant, efficient, and inspection-ready new year, we’ve created the MedTech Naughty & Nice List from a Quality perspective—a festive reminder of what you’re doing right and what may earn you a lump of coal… or worse, a 483.

🎁 The NICE List: Quality Behaviors Worth Celebrating

These are the actions that put you firmly in the Quality gold star category. If your team is doing even half of these, you’re already giving Santa a reason to smile.

✔️ You built your QMS early—and treated it like a strategic asset

Instead of waiting until “we’re closer to submission,” you implemented your Quality System early, letting it guide development rather than slow it down. You recognize that Quality is not overhead or bureaucracy—it’s the infrastructure that protects your patients, your company, and your investors.

✔️ You document as you go (not when someone asks for it)

Your design files, test records, and decisions are written down, controlled, and accessible. Teams don’t need to dig through Slack messages or old email chains to understand what changed and why. That level of discipline is Quality’s equivalent of freshly baked cookies.

✔️ You treat Risk Management as a living, breathing process

From early design to post-market surveillance, you continuously update and refine your risk files. You understand that risk doesn’t hibernate—it evolves as your product evolves.

✔️ Your design inputs and outputs are clear, measurable, and testable

You don’t rely on vague statements like “easy to use” or “robust performance.” Your requirements are specific and aligned with user needs. You’ve built traceability from the start, which means your future verification team will want to put your name on their Nice List, too.

✔️ You perform structured, documented Design Reviews

Not rushed, not performative—actual reviews with the right cross-functional people, an independent reviewer, clear minutes, and action items for follow up.. It's rare, magical, and just as bright as Rudolph’s nose.

✔️ You validate your test methods and equipment

You don’t skip straight to testing and pray the results make sense. You prove your measurements are accurate and repeatable. Santa admires your scientific integrity.

✔️ Your DHF, DMR, and DHR are clean and organized

Your Design History File is complete, up to date, and audit-ready. Your manufacturing documentation is clear. Your records are something you could show off at a holiday party (hypothetically).

✔️ You take CAPA seriously

You don’t close corrective actions with vague “operator error” explanations. You investigate root causes, implement sustainable fixes, and verify their effectiveness. You treat CAPA as continuous improvement—not punishment.

✔️ You actively manage and qualify your suppliers

You know that your product is only as good as your supply chain. You’ve vetted, evaluated, and monitored vendors rather than assuming everything will magically work out. Santa loves teamwork—and so do regulators.

✔️ You train your team and maintain proof

Everyone knows what they’re responsible for, and you can demonstrate competence with training records. Nothing warms a Quality professional’s heart like a complete training matrix.

🎅 The NAUGHTY List: Quality Practices That Could Get You Coal (or a 483)

We all slip into bad habits sometimes, but some behaviors are risky enough to land you on the naughty list. If you recognize your team in any of these… it may be time to make some New Year’s resolutions.

❌ “We’ll deal with Quality later”

This is the #1 Quality sin of early-stage MedTech teams. Delaying QMS implementation until late development is like building a house and adding the foundation last. You end up reworking everything—and paying for it twice.

❌ No design controls, but plenty of prototypes

If your development cycle is:build → test → shrug → repeat,you’re not just being inefficient—you’re creating regulatory risk.

❌ Using uncontrolled or outdated documents

If your files are named things like Design_FINAL_v3_REALLY_FINAL_THIS_ONE.docx, you’re playing a dangerous game. Regulators expect version control, not creative file naming.

❌ Confusing verification with validation

These concepts aren’t interchangeable.

• Verification confirms you built the device correctly.

• Validation confirms you built the right device. Santa can tell the difference—and so can your reviewer.

❌ Risk Management Files that haven’t been updated since your seed round

If your Risk Management File hasn’t changed in a year while your design has pivoted three times, you’ve earned yourself a spot on the Naughty List.

❌ Making changes without change control

Switching critical suppliers, changing materials/design features/process requirements, or updating software without documenting and assessing the impact is a classic early-stage Quality misstep. It’s the regulatory equivalent of changing Santa’s cookie recipe and hoping he won’t notice.

❌ Ignoring complaints and post-market signals

Even “minor” complaints are important data. Pretending they don’t matter is both non-compliant and risky.

❌ Relying on vendor assurances as “evidence”

If your supplier says, “Trust us, it’s good :)” and you file that as proof, you may want to start preparing for audit season.

🎄 Final Thoughts: Give Yourself (and Your Future Auditors) the Gift of Good Quality

Quality isn’t about perfection—it’s about building trustworthy processes, protecting patients, and creating a foundation for sustainable growth. The holidays are a perfect time to assess where you’re excelling and where you need to refocus, so you can enter the new year stronger, more compliant, and ready for anything.

If your team is leaning a little too far into the Naughty List this year, don’t worry. Every startup goes through growing pains—and the good news is, quality maturity is absolutely achievable with the right support and structure.

Need some help getting started? Learn more about the services we provide or ask a question to our team of experts, ready to help you take flight!