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Regulations and Standards For The Lifecycle Of Medical And IVD Devices

 Claudio Barella
  3rd-May-2017
Description: The international regulatory framework for regulations and standards for the lifecycle of medical and IVD devices (hardware and software) has evolved over the past twenty years and is still evolving. Medical errors as the cause of nearly 100,000 deaths per year in the US healthcare system”. Each market area has defined specific regulations taking into account the international unified standard ISO and IEC, however, they require adjustments to the local regulations.
Views: 867
Domain: Medical
Category: Implants
Contributing Organization: Endovespa Project
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Contents:
Medical & IVD Devices Regulations and Standards

Regulations and standards for the
lifecycle of medical and IVD devices
(hardware and software)
Claudio Barella

Istituto di BioRobotica Scuola Superiore Sant’Anna

Pontedera, 2016-02-10
1

Medical & IVD Devices Regulations and Standards
Summary
• # Part 1: The international regulatory framework
• # Part 2: specific regulations for e ... See more
Claudio Barella
06 December, 2016