Regulatory Requirements for Medical Devices

A network of laws and standards regulates the development and marketing of medical devices. These regulations determine which development phases are necessary and which evidence must be provided regarding the product's suitability, safety, and performance if it is to be tested on humans and ultimately placed on the market.

The book introduces the regulatory framework of medical device development and briefly explains the relevant regulatory terms such as clinical evaluation, clinical trial, clinical studies, and health technology assessment. These must be internalized by all those involved and receive the same attention in the development process as the purely technical-medical product requirements from the perspective of the user or the market.

In this book, medical device developers will find support for the regulatory classification of their products and the definition of the necessary development steps depending on the respective risk class and intended purpose. The book, therefore, along the entire process chain, offers practical guidance in the form of checklists, decision trees, reporting guidelines, and annotated SOP lists.

 
R. Mildner (Ed.):
Regulatorische Anforderungen an Medizinprodukte
Einführung und Handlungshilfen - von klinischer Bewertung bis HTA

1st edition, 154 pages, December 2011
€ 39.95 [D], ISBN: 978-3-941468-29-0

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