🎄 The Medtech Product Documentation Naughty & Nice List

A Startup-Friendly Guide to Staying on the Right Side of Regulatory Expectations

In the world of medtech innovation, documentation isn’t the glamorous part of bringing a device to life, but it is one of the most critical. Great documentation protects your company, accelerates your regulatory path, and helps you scale. Poor documentation? It slows you down, triggers rework, and puts you at risk when regulators come knocking.

To help medtech startups stay on track, we put together this Product Documentation Naughty & Nice List, a practical, founder-friendly guide to what accelerates progress… and what silently derails it.

🎁 The NICE List

These practices set your startup up for speed, clarity, and regulatory confidence.

✅ Keeping documentation current

The strongest medtech teams treat documentation as a continuous process, not a box-checking exercise saved for later. When design changes happen in real time, documentation should follow. Up-to-date documentation reduces backtracking, aligns cross-functional teams, and ultimately accelerates your regulatory submissions.

✅ Clear, traceable requirements

This is the backbone of medical device development. Strong documentation has a clean thread from:

User Needs → Design Inputs → Design Outputs → Verification → Validation

A complete traceability matrix not only supports regulatory clarity but ensures engineering, clinical, and quality teams are always building toward the same goals.

✅ Version control that actually controls versions

A single source of truth is essential. Whether you use an eQMS, or controlled SharePoint, your documentation should be centralized, controlled, and accessible.

Good version control prevents duplicated files, outdated specifications, and contradictory instructions, issues that can derail audits and confuse engineering teams.

✅ Documenting rationale, not just outcomes

Regulators want to understand how decisions were made, not just the end result. When you capture the “why” behind your design choices, risk decisions, and requirement definitions, you demonstrate a mature and thoughtful development process.

This is especially important for novel technologies or emerging clinical workflows that require clear justification.

✅ Usable, readable documents

Documentation is most effective when it can be understood quickly. Clean formatting, consistent structure, and clear language help your internal teams move faster and reduce the risk of misinterpretation or downstream errors. Good documentation isn’t just compliant, it’s operationally actionable.

🎅 The NAUGHTY List

These habits might feel harmless now, but they create major problems in audits, submissions, and scaling.

❌ “We’ll document it later…”

Every startup says it at some point. Unfortunately, "later" usually means after several more design iterations, when key details are already lost. Documentation debt piles up quickly and forces teams into stressful catch-up cycles before audits or submissions.

Proactive documentation saves time and sanity.

❌ One-line design inputs

When design inputs are vague or oversimplified, testing becomes nearly impossible. Regulators expect measurable, testable, objective requirements. One-liners might feel fast in the moment but create confusion, inconsistent development, and verification failures later.

❌ Shadow documents saved on personal drives

If documentation isn’t in your controlled system, it doesn’t exist from a regulatory standpoint. Shadow documents create misalignment and risk untraceable changes, one of the most common and preventable audit findings.

Centralized documentation is non-negotiable. When editing documents, download them directly from the controlled system and edit them with track changes on.[NO1] [MB2] 

❌ Missing links between requirements and tests

If you can’t trace a requirement to a test, or vice versa, you introduce gaps that regulators view as high risk. Missing traceability slows down submissions, complicates verification and validation, and undermines confidence in your development process. Our team can help you establish a traceability matrix to highlight gaps. This takes the guesswork out of it!

❌ Copy-paste outputs from old products

Leveraging prior templates is fine; copy-pasting old content is not. Each device has unique risks, features, and requirements. Recycled content introduces inaccuracies, outdated assumptions, and inconsistencies that auditors spot immediately.

Documentation should reflect this product, not the last one.

🎄 Final Thoughts

Product documentation is more than a regulatory requirement, it's a strategic advantage. Startups that build strong documentation practices early move faster, iterate with confidence, and avoid costly redesigns or submission delays. Whether you're building your first prototype or preparing for a pivotal study, staying on the “Nice List” helps you build a safer, stronger, and more scalable medical device.

Need help staying on the nice list? We are here to help! Reach out today to get started.