CourseRisk Management for Medical Devices
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01 July 2024
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Zoom
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6 Hours
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English
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15:00-21:00 Brussels
- 14:00-20:00 UK
- 09:00am-03:00pm New York
$700
Until 31 May 2023
$780
Until 27 Jun 2024
$900
Until 01 Jul 2024
Lecturer: Gadi Shtepel
Gadi brings with him over 30 years of experience in the fields of Quality Assurance and Regulatory Affairs in the Medical Device companies.
Gadi held some key positions in the Medical Device Industry for devices under the FDA and EU regulations and was a Lead Auditor for a leading EU Notified Body.
Gadi holds a B.Sc in Engineering from the Techinon - The Israeli Institute of Technology.
Gadi held some key positions in the Medical Device Industry for devices under the FDA and EU regulations and was a Lead Auditor for a leading EU Notified Body.
Gadi holds a B.Sc in Engineering from the Techinon - The Israeli Institute of Technology.
The Risk Management process is a mandatory regulatory requirement for Medical Device manufacturers. The FDA–QSR the EU MDR/IVDR and ISO 13485 include explicit requirements for Risk Management. The Risk Management process includes identifying risks, evaluating the level of each risk and reducing the risks level by effective mitigations. Some of the risks are also used as Design Input for the Design &d Development process.
During this course the topics of Risk Management will detailed including effective methods and tools.
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