Medical Devices and In Vitro Diagnostics: Requirements in Europe

ISBN-13: 9783031220906 / Angielski / Twarda / 2023 / 680 str.

Christian Baumgartner; Johann Harer; Jörg Schröttner

Opis

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. 

Spis treści

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.-

O autorze

​Univ.-Prof. Dipl.-Ing. Dr. techn. Christian Baumgartner, PhD has been Professor and Head of the Institute of Health Care Engineering with European Testing Center of Medical Devices at Graz University of Technology, Austria. He received his MSc (1994) and PhD degree (1998) from Graz University of Technology, Austria, his habilitation degree in Biomedical Engineering from UMIT, Tyrol, Austria (2006). Diploma in organ and conducting (1998) from the Conservatory of Graz, Austria.

From 1998-2002 Dr. Baumgartner held a R&D position at Tecan.com, where he co-developed confocal fluorescence laser scanning systems for microarray applications. From 2007-2008, he joined the Barnett Institute of Chemical and Biological Analysis, Northeastern University and Harvard Medical School, Boston, MA, where Dr. Baumgartner worked in the field of bioinformatics for biomarker discovery. In 2009, he was appointed Full Professor and Director of the Institute of Electrical and Biomedical Engineering at UMIT Tirol. Since 2015 he is the Head of the Institute of Health Care Engineering with European Testing Center of Medical Devices at Graz University of Technology, Austria. Dr. Baumgartner is the author of more than 180 publications in refereed journals, books and conference proceedings, and patents and is a reviewer for more than 40 scientific journals. He served as a deputy editor of the Journal of Clinical Bioinformatics, is section editor of Sensors (section biomedical sensors), co-section editor of the IMIA Yearbook of Medical Informatics (sensors, signals and imaging informatics), and is an editorial board member of Cell Biology and Toxicology and Methods of Information in Medicine. His main research interests include biomedical sensors, cellular electrophysiology and signal processing, biomedical modeling and simulation, clinical bioinformatics, machine learning and computational biology, and medical device development, safety and regulatory affairs.

Dipl.-Ing. Dr. Johann Harer studied electrical engineering at the Technical University of Graz and law at the Karl Franzens University in Graz. 1980 first industrial experience as developer and project manager for medical instruments at an Austrian company. 1986 to 1990 working for an international company in the field of telecontrol systems and industrial automation in Germany. 1990 start at AVL Medical Systems, responsible for business development. Subsequently responsible for various additional functions, including global system support and product management. 2001 to 2014 at Roche Diagnostics, among others as global head QM of the business unit Near Patient Testing as well as head QM, QA & Regulatory Affairs at Roche Diagnostics Graz. 2014 to 2022 Managing Director at Human.technology Styria GmbH. Since November 2022 Project Manager and Senior Technical Expert at QMD Services GmbH, a notified Body for Medical Products and in Vitro Diagnostic Products according EU 2017/745 and 2017/746. Regular trainings and lectures as well as auditing activities and company assessments within the framework of EN ISO 13485 and the EFQM Business Excellence Model.

Assoc.-Prof. Dr. Jörg Schröttner is currently an Associate Professor at the Institute of Health Care Engineering with European Testing Center of Medical Devices at Graz University of Technology, Austria. He received his MSc (2000), PhD degree (2003) and his habilitation degree in Health Care Engineering (2008) from Graz University of Technology, Austria.

From 2000-2003 Dr. Schröttner held a research and teaching assistant position at the Institute of Biomedical Engineering at Graz University of Technology, Austria. From 2003-2008 he was deputy head of the Institute of Clinical Engineering with European Notified Body (PMG), where he developed the conformity assessment procedures of quality management systems for active medical devices according to the medical device directives. Since 2008 he is the deputy head of the Institute of Health Care Engineering and in 2014 he became the head of the European Testing Center of Medical Devices, formerly European Notified Body. In view of current socio-demographic developments, Dr. Schröttner’s scientific work deals with methodological, technical,  organizational, economic and quality assuring aspects of intra- and extramural health care, with a special focus on patient safety. The goal is to help patients cure or alleviate their illness efficiently, economically, without adverse events and in a quality-assured manner. He is the author of more than 100 publications in reviewed journals, books and conference proceedings, and patents. Dr. Schröttner has also been active in the field of medical device approval at the state-accredited Testing and Certification Body for Medical Devices for over 20 years. He is an expert in the development, manufacturing and testing of active medical devices and is lead auditor for quality management systems according to EN ISO 13485 and EN ISO 9001.