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

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