Only available as e-book!Medical software encompasses many software products that are used in a therapeutic or diagnostic context. Due to the digitization of healthcare systems, the importance of these products is increasing. From a regulatory point of view, two types can essentially be distinguished: embedded software as an integral part of a medical device and stand-alone software like a medical app, which itself is a medical device. Recently, the European legislature has drastically tightened the requirements for medical devices, and it is therefore expected that small and medium-sized manufacturers will be particularly affected by these changes. This book is a comprehensive guide to facilitating market access. It covers the following topics:
• From idea to product – what are the current best practice approaches?
• Stricter legal requirements – what manufacturers need to know and how the new requirements can be optimally fulfilled.
• Standards for conformity – which standards need to be considered by the manufacturer and what are the pitfalls of their practical application?
The author team is composed of well-known experts for software development, medical device legislation, data protection legislation, liability legislation, application of standards and product testing.
Dr. Thorsten Prinz is scientific staff at DGBMT – German Society for Biomedical Engineering in the VDE Association for Electrical, Electronic & Information Technologies.