CourseDesign Control for Medical Devices
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20 June 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
$780
Until 13 Jun 2024
$900
Until 20 Jun 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.
Design Control process is a mandatory regulatory requirement for Medical Device manufacturers. The FDA–QSR the EU MDR/IVDR and ISO 13485 include explicit requirements for Design Control. The Design & Development activities include: Planning, Designs Input, Design Output, Design Verification & Validation and Design Transfer to production.
During this course the topics of Risk Management will detailed including effective methods and tools.
Content:
- Regulatory Requirements
- Design & Development Planning
- Design Input (link to Risk Management)
- Design Output
- Design Review
- Design & Development Verification
- Statistical Sampling for V&V
- Design & Development Validation
- Design Transfer
- Design & Development Changes
- Design History File (DHF)
- Technical File
- DMR
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