Write It Right: A Practical Guide to Medical Device Regulatory Writing

Clear writing gets devices approved. Vague writing gets deficiency letters.

Most regulatory submissions fail because of how the evidence is presented, not because the evidence is missing. Notified body reviewers flag unsupported claims, inconsistent terminology, hedged conclusions, and documents that do not trace back to one another. Write It Right is a practical field guide to fixing those problems before a reviewer finds them.

Written by Dr. Hafez Selim, MD, PhD, a physician-scientist with more than two decades of experience in medical device safety, clinical evaluation, and regulatory affairs, this book focuses on the documents that matter most under the EU Medical Device Regulation (MDR 2017/745): technical documentation, clinical evaluation reports, risk management files, post-market surveillance reports, and responses to notified body questions.

Inside you will learn how to:

- Structure regulatory documents so reviewers can find and verify every claim

- Replace vague, hedged language with precise, evidence-backed statements

- Keep terminology, device descriptions, and claims consistent across the whole technical file

- Write clinical evaluation and safety conclusions that stand up to scrutiny

- Respond to deficiency questions clearly, completely, and on the first attempt

Each chapter includes practice exercises, with a full answer key at the back of the book, so you can apply the principles right away rather than just read about them.

Whether you are a regulatory affairs specialist, medical writer, clinical or quality professional, or an engineer who has been handed a technical file for the first time, Write It Right gives you the tools to produce documentation that is clear, defensible, and ready for review.