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Writing In-House Medical Device Software in Compliance With EU, UK, and US Regulations

Writing In-House Medical Device Software in Compliance With EU, UK, and US Regulations

First edition

Hardback (26 Mar 2024)

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Publisher's Synopsis

This book is a comprehensive guide to producing medical software for routine clinical use. It is a practical guidebook for medical professionals developing software to ensure compliance with medical device regulations for software products intended to be sold commercially, shared with healthcare colleagues in other hospitals, or simply used in-house.

It compares requirements and latest regulations in different global territories, including the most recent EU regulations as well as UK and US regulations.

This book is a valuable resource for practising clinical scientists producing medical software in-house, in addition to other medical staff writing small apps for clinical use, clinical scientist trainees, and software engineers considering a move into healthcare. The academic level is post-graduate, as readers will require a basic knowledge of software engineering principles and practice.

Key Features:

  • Up to date with the latest regulations in the UK, the EU, and the US
  • Useful for those producing medical software for routine clinical use
  • Contains best practice

Book information

ISBN: 9781032293486
Publisher: CRC Press
Imprint: CRC Press
Pub date:
Edition: First edition
DEWEY: 610.28553
DEWEY edition: 23/eng/20240228
Language: English
Number of pages: 278
Weight: 635g
Height: 234mm
Width: 156mm
Spine width: 18mm