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

ISBN-13: 9781032293509 / Miękka / 2024 / 272 str.

Matthew Memmott

Opis

This book is a comprehensive guide to producing medical software for routine clinical use.

Spis treści

1. Introduction. 2. The Continuing Need for In-House Software Development. 3. Types of Health Software. 4. Basic Concepts of Risk and Safety. 5. Standards and Guidelines. 6. The Regulation of Medical Devices. 7. Best Practice and Legal liability. 8. Cybersecurity of Medical Devices. 9. The Future of Medical Device Regulation. 10. Summary. Index.

O autorze

Philip worked as a clinical scientist (medical physicist) in the UK National Health Service for nearly 40 years, specialising mainly in nuclear medicine. He producing in-house data analysis software for that whole period, with an emphasis on software quality assurance. He was a UK delegate on a pioneering EU project (COST-B2) on quality assurance of nuclear medicine software and he has contributed to numerous reports published by the UK Institute of Physics and Engineering in Medicine (IPEM). He retired from the NHS in 2016 but has remained professionally active, with continued contributions to IPEM publications and a chapter in a recently published book entitled Diagnostic Radiology Physics with MATLAB®. He is a recognised expert on the application of EU and US medical device legislation, as well as other consumer protection legislation that may affect the in-house medical software developer. His current interests include the application of AI methodologies to diagnostic imaging and the future role of medical apps. Matthew Memmott is a Consultant Clinical Scientist at Manchester Royal Infirmary, UK.