Clinical Evaluation and Investigation of Medical Devices under the new EU Regulation

  • Author : Wolfgang Ecker
  • Publsiher : BoD – Books on Demand
  • Release : 04 June 2020
  • ISBN : 9783751937665
  • Page : 280 pages
  • Rating : 4/5 from 21 voters

Download or read online book entitled Clinical Evaluation and Investigation of Medical Devices under the new EU Regulation written by Wolfgang Ecker and published by BoD – Books on Demand. This book was released on 04 June 2020 with total page 280 pages. Available in PDF, EPUB and Kindle. Get best books that you want by click Get Book Button and Read as many books as you like. Book Excerpt : The concept of clinical evaluation and the framework for clinical investigations have been significantly enforced within the new EU-Medical Device Regulation (MDR). This book provides in-depth and practice-oriented guidance on the systematic identification and generation of clinical data through clinical investigations and other relevant sources. It addresses the needs of all stakeholders, be it manufacturers, notified bodies or competent authorities, when they have to plan, perform or assess clinical evaluations and investigations for medical devices on the way to conformity assessment and CE marking. It is a valuable tool of qualification for clinicians and related experts when preparing for a role of a clinical evaluator in the field, either when serving any of the stakeholders or when trying to make their own involvement stand out in start-ups. spin-offs or other development projects or in counselling services.

Clinical Evaluation and Investigation of Medical Devices under the new EU Regulation

Clinical Evaluation and Investigation of Medical Devices under the new EU Regulation
Author: Wolfgang Ecker,Gerold Labek,Tarquin Mittermayr,Brigitte Raffeiner,Michael Ring,Bernhard Schwartz
Publisher: BoD – Books on Demand
Relase: 2020-06-04
ISBN: 9783751937665
GET BOOK

Sterilisation of Biomaterials and Medical Devices

Sterilisation of Biomaterials and Medical Devices
Author: Sophie Lerouge,Anne Simmons
Publisher: Elsevier
Relase: 2012-09-27
ISBN: 9780857096265
GET BOOK

Emerging Nanotechnologies for Diagnostics Drug Delivery and Medical Devices

Emerging Nanotechnologies for Diagnostics  Drug Delivery and Medical Devices
Author: Ashim K Mitra,Kishore Cholkar,Abhirup Mandal
Publisher: William Andrew
Relase: 2017-02-13
ISBN: 9780323429979
GET BOOK

Handbook of Polymer Applications in Medicine and Medical Devices

Handbook of Polymer Applications in Medicine and Medical Devices
Author: Kayvon Modjarrad,Sina Ebnesajjad
Publisher: Elsevier
Relase: 2013-12-05
ISBN: 9780323221696
GET BOOK

Nanoparticles in Analytical and Medical Devices

Nanoparticles in Analytical and Medical Devices
Author: Fang Gang
Publisher: Elsevier
Relase: 2020-09-25
ISBN: 9780128211632
GET BOOK

Medical Devices

Medical Devices
Author: World Health Organization
Publisher: World Health Organization
Relase: 2010
ISBN: 9789241564045
GET BOOK

Medical Devices

Medical Devices
Author: Bertil Jacobson,Alan Murray
Publisher: Elsevier Health Sciences
Relase: 2007
ISBN: 9780443102592
GET BOOK

Plastics in Medical Devices

Plastics in Medical Devices
Author: Vinny R. Sastri
Publisher: Elsevier
Relase: 2010-03-05
ISBN: 9780815520283
GET BOOK

Medical Devices FDA Faces Challenges in Conducting Inspections of Foreign Manufacturing Establishments

Medical Devices  FDA Faces Challenges in Conducting Inspections of Foreign Manufacturing Establishments
Author: Marcia Crosse
Publisher: DIANE Publishing
Relase: 2008-12
ISBN: 9781437905274
GET BOOK

Medical Devices

Medical Devices
Author: Seeram Ramakrishna,Lingling Tian,Charlene Wang,Susan Liao,Wee Eong Teo
Publisher: Woodhead Publishing
Relase: 2015-08-18
ISBN: 9780081002919
GET BOOK

Medical Devices

Medical Devices
Author: Christa Altenstetter
Publisher: Routledge
Relase: 2017-09-08
ISBN: 9781351506281
GET BOOK

Medical Devices

Medical Devices
Author: United States. Congress. House. Committee on Interstate and Foreign Commerce. Subcommittee on Public Health and Environment
Publisher: Unknown
Relase: 1974
ISBN: LOC:0018385320A
GET BOOK

Electrically Active Materials for Medical Devices

Electrically Active Materials for Medical Devices
Author: Syed A M Tofail,Joanna Bauer
Publisher: World Scientific
Relase: 2016-08-04
ISBN: 9781783269884
GET BOOK

Medical Devices

Medical Devices
Author: United States. General Accounting Office
Publisher: Unknown
Relase: 1988
ISBN: UOM:39015022612488
GET BOOK

Medical Devices

Medical Devices
Author: United States. Food and Drug Administration
Publisher: Unknown
Relase: 2021-08-03
ISBN: MINN:30000010715898
GET BOOK