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The highly-anticipated fifth edition is here! Get the must-have resource for achieving compliance with medical device regulations.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
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The second edition of Regulatory Writing: An Overview presents a writer’s-eye view of regulatory documentation intended to help writers, reviewers, and readers of regulatory documentation to better understand the varied aims and audiences of these complex documents. Novice writers as well as seasoned professionals will benefit from this new edition. Regulatory Writing is an invaluable resource for any professional engaged in designing, composing, compiling, or commenting on regulatory documentation. The authors have cited relevant guidelines, industry guidance, publication guides, and collaborative efforts to streamline, harmonize, and advance the production of high-quality regulatory documentation.
Every chapter has been updated to reflect new regulations and guidance. Some of these changes were substantial, especially in light of the COVID-19 public health emergency.
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Published by RAPS © 2020. Hardcover. 288 pages. ISBN: 978-1-947493-55-1.