Medical Device School – Process Validation or Verification?
When you need to prove that your product conforms to the Specification, Process Validation or Verification is a good question you should ask yourself.
Monir El Azzouzi and Stefan Bolleininger will guide you so you can decide if you should perform validation or verification.
We will also present you with some tools and tricks to find some answers to your questions.
Who is Monir El Azzouzi
Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs.
After working for many years with big Healthcare company and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world.
He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses…
Who is Stefan Bolleininger
Stefan Bolleininger is a key opinion leader and speaker for the medical device regulation MDR in Europe.
He founded the be-on-Quality GmbH consulting agency to passionately support manufacturers during CE approvals or FDA approvals. This support covers the full chain of quality and regulatory requirements: Implementation, maintenance, audits, assessments, and inspections.
In the area of “Risk Management and Usability for Medical Devices and Medical Networks”, he holds a teaching assignment at the Technical University of Nuremberg and the VDI Technical Committee “Quality Assurance for Software in Medical Devices”.
Links
- AQL application: https://apps.apple.com/us/app/aql/id608818916
- Stefan Bolleininger Linkedin: https://www.linkedin.com/in/stefan-bolleininger-3a717028/
- Monir El Azzouzi Linkedin: https://www.linkedin.com/in/melazzouzi/
- Process Validation or Verification Blog post: https://easymedicaldevice.com/medical-device-validation/
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