1st Edition
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
1. Introduction. 2. The Need for In-House Development of Medical Software. 3. Types of Health Software. 4. Basic Concepts of Risk and Safety. 5. Standards and Guidelines. 6. Regulation of Medical Devices. 7. Best Practice and Legal Liability. 8. Security of Medical Devices. 9. Future Regulation of Medical Device Software. 10. Summary. Index.
Biography
Philip S. Cosgriff worked as a clinical scientist (medical physicist) in the UK National Health Service for nearly 40 years, specialising mainly in nuclear medicine. He produced 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 J. Memmott is a consultant medical physicist based at Manchester University NHS Foundation Trust, with experience working as a clinical scientist in the UK National Health Service for over 15 years. He has previously published journal articles, book chapters and delivered talks at national and international conferences on topics ranging from Monte Carlo image generation, computational phantoms and cardiac positron emission tomography (PET‑CT) optimisation to dosimetry for radiation accident scenarios. He has a long‑standing interest in scientific programming, utilising various languages for analysis and simulation of ground truth quality assurance data; and commercial platforms for the development of in‑house clinical applications. He was a previous Chair of the UK Institute of Physics and Engineering in Medicine (IPEM) Nuclear Medicine Software Quality Group (NMSQG); a group which develops national audits to promote quality standards across departments utilising in‑house developed software, as well as commercial packages. His current interests are in modelling exposure scenarios from radiation accidents, developing ground‑truth computational phantoms for software quality assurance, investigating novel quantitative methods in PET‑CT studies and the potential applications of AI in nuclear medicine.
This book is a comprehensive and meticulously researched guide and a beacon. It is a testament to the collaborative effort to make medical software development a safe, reliable, and efficient process. It is a bridge between the world of software engineering and the stringent requirements of medical device regulation, offering a path for those committed to advancing healthcare through technological innovation. As the reader embarks on this enlightening journey, they are equipped not just with knowledge, but with a perspective that balances regulatory compliance with the endless possibilities of software in healthcare.
- Johan Helmenkamp, Product Specialist at Canon Medical Systems, and formerly Medical Physicist at Karolinska University Hospital, Stockholm, Sweden
This is a book that should be read by all healthcare scientists, both those in training and long-standing professionals as well as entrepreneurs seeking to develop healthcare related software. Whilst not all healthcare scientists will develop software for medical applications all will use, evaluate and test software throughout their professional careers. Whilst the regulation and legal implications of software within the healthcare sector is subject to rapid change this book provides an in-depth review of the current regulatory and legal frameworks in the UK, EU and US jurisdictions and provides pointers to changes expected in the short term. It provides advice as to how software developers may comply with these frameworks with a specific emphasis on the implications for software developed by employees for use within a specific healthcare institution.
It is a book borne out of many years’ experience by the authors in writing software to be used within their own departments as well as supporting their colleagues in other organisations. It highlights the difficulties faced by healthcare institutions in accepting the risks and responsibilities of using in-house developed software and the need for healthcare scientists to engage with organisational management at the highest level. The requirements for software development standards, risk management and quality management in relation to medical device and healthcare related software are clearly laid out. The authors argue that these requirements may lead to in-house software development being restricted to large institutions with dedicated, highly trained software teams capable of developing and maintaining software to the required standard. The authors have provided the reader with an immense resource with which to understand and evaluate the pitfalls and benefits of developing and using medical device software especially where developed within the healthcare institution. Not an easy read but a must read!
- Peter Jarritt, Director - Orion MedTech, May 2024.
