How to Classify Your Medical Device Under European Regulations

ISBN-13: 9781774691878 / Angielski / Twarda / 2021 / 261 str.

Shalinee Naidoo

Spis treści

• Chapter 1 Introduction to Medical Devices
• Chapter 2 Medical Device Use and Regulation
• Chapter 3 Overview of the CE Mark Process
• Chapter 4 History of Medical Devices
• Chapter 5 The Medical Device Directive 93/42 EEC
• Chapter 6 The Medical Device Regulation MDR 2017/745
• Chapter 7 Overview of Medical Device Classification
• Chapter 8 Understanding the EU Guidelines on Medical Device Classification
• Chapter 9 Understanding EU Classification Rules under the MDR 2017/745
• Chapter 10 Medical Device Nomenclature