New publication Medical Technology
ZULASSUNG VON MEDIZINPRODUKTEN
IN DEN USA UND GMP ANFORDERUNGEN
Ein praxisorientierter Ratgeber.
By Daniel Shoukier | BellingsBooks Publishing House
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ISBN 978-3-9523794-0-0 | Price in EUR: 98.00
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|Number of pages||336|
This FDA Kompendium is written from a practitioner for all the colleagues who are looking for an overview over the FDA Regulation to get a quick information. The Content provides an overview of the general admission requirements for medical devices and the requirements for a GMP.
ABOUT THE AUTHOR
Daniel Shoukier is a worldwide-recognized regulatory expert for medical devices and a book author of several publications. He is the Managing Director of the Bellingswood Group, a consulting company for global market access and registration of medical devices and drug combination products. He is also a lead auditor and medical expert for a Swiss notified body. As a lecturer for professional academies he provides his student a deep understanding into the complex world of medical device regulation.
In the past, Daniel was the Vice President at Novo Nordisk, heading up Regulatory Affairs for medical devices. Before this he was the Global Director for regulatory affairs at Biosensors and Olympus Medical. He also worked in the past as a lead auditor at TÜV Rheinland.