Development and Production of Medical Software

Standards in Medical Engineering

Cite this publication as

Thorsten Prinz (Hg.), Development and Production of Medical Software (2018), VDE Verlag, Berlin, ISBN: 9783800745388

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Descripción / Abstract

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?

Extracto

Índice

  • Development and Production of Medical Software
  • Impressum
  • Authors
  • Table of Contents
  • 1 Preface
  • 2 Introduction
  • 3 Legal Requirements
  • 3.1 Approach to determining the legal implications
  • 3.2 Software as a medical device
  • 3.3 Legal Requirements for medical devices
  • 3.4 Requirements from other fields of law
  • 3.5 The road to certification of medical software
  • 3.6 Medical software in the market
  • 3.7 Jurisdiction of the notified bodies and national authorities
  • 3.8 Peculiarities of markets outside the EU
  • 4 Medical software – from the idea to the finished product
  • 4.1 Product idea
  • 4.2 Development of Medical Software
  • 4.3 The development process
  • 5 The benefit of standards
  • 5.1 Background on standardization
  • 5.2 Standards on producing conformity with the legal requirements
  • 5.3 Process standards
  • 5.4 Product standards
  • 5.5 Standards with additional area of application
  • 5.6 Index of standards and guidelines
  • 6 Prospects
  • 6.1 Future factors which will affect the European legal framework
  • 6.2 The future role of standards
  • 6.3 Notified bodies – from partner of the manufacturers to the long arm of the authorities
  • 6.4 Future standards projects regarding medical software
  • 7 Abbreviations/acronyms
  • 8 References and web links
  • 8.1 References
  • 8.2 Web links
  • 9 Annex
  • 9.1 Questions for determining the legal implications
  • 9.2 Stakeholders with influence on the legal implications
  • 9.3 Conformity assessment procedure of the European regulations
  • 9.4 Classification according to the European MDR
  • 10 Acknowledgement
  • Readers - Content - Authors

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