Main description:

This updatable reference work gives a comprehensive overview of all relevant regulatory information and requirements for manufacturers and distributors around medical and in-vitro diagnostic devices in Europe. These individual requirements are presented in a practice-oriented manner, providing the reader with a concrete guide to implementation with main focus on the EU medical device regulations, such as MDR 2017/745 and IVD-R 2017/746, and the relevant standards, such as the ISO 13485, ISO 14971, among others. This book offers a good balance of expert knowledge, empirical values and practice-proven methods. Not only it provides readers with a quick overview about the most important requirements in the medical device sector, yet it shows concrete and proven ways in which these requirements can be implemented in practice. It addresses medical manufacturing companies, professionals in development, production, and quality assurance departments, and technical and medical students who are preparing themselves for a professional career in the medical technlogy industries.

Contents:

Quality Management system.- Risk Management.- Legal Environment and Approval Requirements.- Development of Medical Devices.- Software as a Medical Device.- Safety Requirements.- Clinical Evaluation.- GEP/GMP Compliant Production Facilities.- Process and Method Validation.- Manufacturing and Quality Assurance According to cGMP.- Supplier Management.- Corrective Action and Improvement Management.- The Notified Body.- A Start-Up's Point of View;- etc.