001476405 000__ 05069cam\\22006377i\4500
001476405 001__ 1476405
001476405 003__ OCoLC
001476405 005__ 20231003174419.0
001476405 006__ m\\\\\o\\d\\\\\\\\
001476405 007__ cr\un\nnnunnun
001476405 008__ 230830s2023\\\\sz\a\\\\o\\\\\001\0\eng\d
001476405 019__ $$a1395538911$$a1395946874$$a1396060596
001476405 020__ $$a9783031220913$$q(electronic bk.)
001476405 020__ $$a3031220919$$q(electronic bk.)
001476405 020__ $$z9783031220906
001476405 020__ $$z3031220900
001476405 0247_ $$a10.1007/978-3-031-22091-3$$2doi
001476405 035__ $$aSP(OCoLC)1395575331
001476405 040__ $$aGW5XE$$beng$$erda$$epn$$cGW5XE$$dYDX$$dEBLCP
001476405 043__ $$ae------
001476405 049__ $$aISEA
001476405 050_4 $$aKJE6229.M42
001476405 08204 $$a344.404/2$$223/eng/20230830
001476405 24500 $$aMedical devices and in vitro diagnostics :$$brequirements in Europe /$$cChristian Baumgartner, Johann Harer, Jörg Schröttner, editors.
001476405 264_1 $$aCham :$$bSpringer,$$c2023.
001476405 300__ $$a1 online resource :$$billustrations (some color).
001476405 336__ $$atext$$btxt$$2rdacontent
001476405 337__ $$acomputer$$bc$$2rdamedia
001476405 338__ $$aonline resource$$bcr$$2rdacarrier
001476405 4901_ $$aTissue engineering and regeneration,$$x2731-0566
001476405 500__ $$aIncludes index.
001476405 5050_ $$aRegulatory Framework for Medical Devices and IVDs in Europe -- The Notified Body: The Conformity Assessment Body for Medical Devices in Europe -- Quality Management Requirements in Compliance with European Regulations -- Risk Management for Medical Devices in Compliance with EN ISO 14971 -- Medical Device Development -- Safety Requirements for Medical Devices in Compliance with European Standards -- Software as Medical Device in Europe -- Clinical Evaluation and Clinical Investigations of Medical Devices Under the MDR -- Performance Evaluation and Performance Studies of in Vitro Diagnostic Medical Devices Under the IVDR -- Validation of Methods and Analytical Processes for In Vitro Diagnostics -- Medical Products: Packing and Labeling Requirements -- GMP-Compliant Design for Plants Manufacturing Medical Devices -- Integrated Qualification of Manufacturing Systems for Medical Devices -- How to Implement a Risk-Based and Life-Cycle Approach for Commissioning and Qualification -- Management for Critical Medical Device and IVD Suppliers -- Process Validation for Medical Device Manufacturing -- Manufacturing and Quality Assurance in Compliance with the MDR and IVDR -- Mastering Quality System Audits and Inspections for Medical Devices -- Post-Market Surveillance and Vigilance on the European Market -- A Regulatory Guide for Medical Device Start-Ups in Europe: Challenges and Pitfalls.
001476405 506__ $$aAccess limited to authorized users.
001476405 520__ $$aThis updatable reference work gives a comprehensive overview of all relevant regulatory information and requirements for manufacturers and distributors around medical and in-vitro diagnostic devices in Europe. These individual requirements are presented in a practice-oriented manner, providing the reader with a concrete guide to implementation with main focus on the EU medical device regulations, such as MDR 2017/745 and IVD-R 2017/746, and the relevant standards, such as the ISO 13485, ISO 14971, among others. This book offers a good balance of expert knowledge, empirical values and practice-proven methods. Not only it provides readers with a quick overview about the most important requirements in the medical device sector, yet it shows concrete and proven ways in which these requirements can be implemented in practice. It addresses medical manufacturing companies, professionals in development, production, and quality assurance departments, and technical and medical students who are preparing themselves for a professional career in the medical technlogy industries.
001476405 588__ $$aOnline resource; title from PDF title page (SpringerLink, viewed August 30, 2023).
001476405 650_0 $$aMedical instruments and apparatus$$xLaw and legislation$$zEuropean Union countries.
001476405 655_0 $$aElectronic books.
001476405 7001_ $$aBaumgartner, Christian$$c(Professor of health care engineering),$$eeditor.
001476405 7001_ $$aHarer, Johann,$$eeditor.
001476405 7001_ $$aSchröttner, Jörg,$$eeditor.
001476405 77608 $$iPrint version: $$z3031220900$$z9783031220906$$w(OCoLC)1348635951
001476405 830_0 $$aReference series in biomedical engineering.$$pTissue engineering and regeneration.
001476405 852__ $$bebk
001476405 85640 $$3Springer Nature$$uhttps://univsouthin.idm.oclc.org/login?url=https://link.springer.com/10.1007/978-3-031-22091-3$$zOnline Access$$91397441.1
001476405 909CO $$ooai:library.usi.edu:1476405$$pGLOBAL_SET
001476405 980__ $$aBIB
001476405 980__ $$aEBOOK
001476405 982__ $$aEbook
001476405 983__ $$aOnline
001476405 994__ $$a92$$bISE