Medical Devices and In Vitro Diagnostics : Requirements in Europe / edited by Christian Baumgartner, Johann Harer, Jörg Schröttner.

Format:

Book

Author/Creator:

Baumgartner, Christian.

Contributor:

Harer, Johann.

Schröttner, Jörg.

Series:

Tissue Engineering and Regeneration, 2731-0566

Language:

English

Subjects (All):

Biomedical engineering.

Industrial management.

Technological innovations.

Biomedical Devices and Instrumentation.

Industrial Management.

Innovation and Technology Management.

Local Subjects:

Biomedical Devices and Instrumentation.

Industrial Management.

Innovation and Technology Management.

Physical Description:

1 online resource (671 pages)

Edition:

1st ed. 2023.

Place of Publication:

Cham : Springer International Publishing : Imprint: Springer, 2023.

Summary:

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.-.

Other Format:

Print version: Baumgartner, Christian Medical Devices and in Vitro Diagnostics

ISBN:

9783031220913

3031220919

OCLC:

1395575331