MDR - The New European Medical Device Regulation
BellingsBooks Verlag
978-3-9523794-1-7 (ISBN)
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On 175 pages pages, the new European Medical Device Regulation (MDR 2017/745) describes in 123 articles and
17 annexes the new requirements for the registration and CE marking of medical devices in the EU, which is
replacing the medical device directives (MDD) and the directive for active implantables medical devices (AIMD).
This compendium is a quick overview of the new MDR and is intended to give the interested reader an easier
access to the complex subject matter. The MDR Compendium is predominantly designed as a question-andanswer
text and deals with the most important aspects of the medical device regulation.
HIGHLIGHTS:
Key elements of the new MDR
EU Conformity Assessment Procedures
Economics Operators
Unique Device Identification (UDI) System
The European Databank (Eudamed)
Medical Device Coordination Group (MDCG)
Liability coverage
Authorised representative
Re-classsification of certain medical devices
Scrutiny process for certain class III and Class IIb devices
Reprocessing single-use devices
Products with aesthetic or non-medical purpose
Tissues or cells of human origin
Clinical investigation
Vigilance and Post-Market Surveillance
Daniel Shoukier is a worldwide-recognized regulatory expert for medical devices and a book author of several publications. He is Managing Director of Bellingswood Group, a consulting company for global market access and registration of medical devices and drug combination products. He is also lead auditor and medical expert for a Swiss notified body. As a lecturer for professional academies he provides his students a deep understanding into the complex world of medical device regulation. In the past, Daniel was Vice President at Novo Nordisk, heading up Regulatory Affairs for medical devices. Before this he was Global Director for regulatory affairs at Biosensors and Olympus Medical. He also worked in the past as a lead auditor at TÜV Rheinland.
| Erscheinungsdatum | 19.07.2017 |
|---|---|
| Zusatzinfo | Mit Abbildungen und Checklisten. |
| Verlagsort | 8152 Glattpark |
| Sprache | englisch |
| Maße | 170 x 240 mm |
| Gewicht | 310 g |
| Themenwelt | Informatik ► Weitere Themen ► Bioinformatik |
| Medizin / Pharmazie ► Gesundheitswesen | |
| Technik ► Medizintechnik | |
| Schlagworte | MDR • Medical Device • Medical Device Regulation • Medizintechnik • New European Medical Device Regulation • Regulation • Regulatory Affairs • Zulassung von Medizinprodukten |
| ISBN-10 | 3-9523794-1-7 / 3952379417 |
| ISBN-13 | 978-3-9523794-1-7 / 9783952379417 |
| Zustand | Neuware |
| Informationen gemäß Produktsicherheitsverordnung (GPSR) | |
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