Full 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 medicalstudents who are preparing themselves for a professional career in the medical technlogy industries.
Contents
Regulatory Framework for Medical Devices and IVDs in Europe.- The Notified Body: The Conformity Assessment Body for Medical Devices in Europe.- Quality Management Requirements in Compliance with European Regulations.- Risk Management for Medical Devices in Compliance with EN ISO 14971.- Medical Device Development.- Safety Requirements for Medical Devices in Compliance with European Standards.- Software as Medical Device in Europe.- Clinical Evaluation and Clinical Investigations of Medical Devices Under the MDR.- Performance Evaluation and Performance Studies of in Vitro Diagnostic Medical Devices Under the IVDR.- Validation of Methods and Analytical Processes for In Vitro Diagnostics.- Medical Products: Packing and Labeling Requirements.- GMP-Compliant Design for Plants Manufacturing Medical Devices.- Integrated Qualification of Manufacturing Systems for Medical Devices.- How to Implement a Risk-Based and Life-Cycle Approach for Commissioning and Qualification.- Management for Critical Medical Device and IVD Suppliers.- Process Validation for Medical Device Manufacturing.- Manufacturing and Quality Assurance in Compliance with the MDR and IVDR.- Mastering Quality System Audits and Inspections for Medical Devices.- Post-Market Surveillance and Vigilance on the European Market.- A Regulatory Guide for Medical Device Start-Ups in Europe: Challenges and Pitfalls.-
