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FDA KOMPENDIUM

0001

New product

New publication Medical Technology

ZULASSUNG VON MEDIZINPRODUKTEN
IN DEN USA UND GMP ANFORDERUNGEN
FDA KOMPENDIUM.

Ein praxisorientierter Ratgeber.
By Daniel Shoukier | BellingsBooks Publishing House

For Business customers and bookshops:
Orders please via bestellung@bellingsbooks.com
or phone +41 (0)79 429 1590.

ISBN 978-3-9523794-0-0 | Price in EUR: 98.00

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Data sheet

Book qualitySoftcover
LanguageDeutsch
Number of pages336

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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.

  • Overview of FDA approval
  • 510(k) Premarket Notification
  • Case studies and decision aids 510(k)
  • Workshop 510(k)
  • Premarket Approval (PMA)
  • Labeling
  • Recall of medical devices
  • Medical Device Reporting
  • Postmarket Surveillance Studies
  • Unique Device Identifier (UDI)
  • Quality System Regulation 21 CFR 820
  • Process Validation 21 CFR 820.75
  • FDA Inspection
  • Typical questions of the FDA Inspectors in a FDA Audit
  • Medical Device Single Audit Program (MDSAP)
  • Software Validation
  • Electronic records and electronic signatures
  • Comparison table FDA and CE approval
  • GMP in comparison to ISO 13485
  • Practically GMP Audit-Checklist

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.