Regulators and Notified Bodies judge a medical device by what is written about it. Write It Right is a practical guide to producing regulatory and clinical documents that are clear, traceable and defensible, built around EU MDR (Regulation (EU) 2017/745) with reference to the current FDA framework.

Written by a physician-scientist who spent nearly a decade in safety leadership at a leading global medical device company, the book treats regulatory writing as a craft that can be learned: every claim tied to its evidence, every sentence built to be read once and understood.

Inside you will find:

• Part I, Foundations: what regulatory documents must do, who reads them, and how evidence is ranked and traced
• Part II, The Prose: choosing words, building sentences and paragraphs, and presenting data honestly in tables and figures
• Part III, Pitfalls: the failures that recur across every document type, with weak passages rewritten side by side
• Part IV, Document by Document: the Clinical Evaluation Report (CER), Clinical Investigation Plan and Report, PSUR and PMSR, Instructions for Use and labeling, PMCF plans and reports, responses to Health Authority and Notified Body questions, and complaint and adverse event narratives
• Part V, Tools: checklists, a glossary, template skeletons, a fully worked and annotated clinical investigation report, an exercise answer key, and a one-stop desk reference

Practical exercises and illustrative before-and-after rewrites show exactly how a vague, hedged or untraceable passage becomes one a reviewer can accept.

For regulatory affairs professionals, medical writers, clinical and safety scientists, quality and post-market surveillance teams, and anyone preparing technical documentation for a Notified Body or FDA review.