QMS Implementation for MDR Up-classified Software Medical Devices

Imagine you need to have your product placed on the EU market under the Medical Device Directive MDD before the Medical Device Regulation MDR date of application (May 26th, 2020).
If your product is class I with MDD and up-classified with MDR, you then have an extension of the transition period until May 26th, 2024.
But, because there is a but, you need to place your product on the market under MDD (Self-certified) before the date of application. So how to do that.

Monir El Azzouzi and Stefan Bolleininger are explaining that to you. They are both experts on MDR and can help you navigate through all this.

Look at this LinkedIn Live Replay and don't hesitate to contact them if you have more questions.

Don't hesitate to connect with Monir El Azzouzi on LinkedIn to be Notified when a Live is planned: https://linkedin.com/in/melazzouzi

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► 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...

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► 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”.

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► Links from the Video

­■ Download the presentation: https://mailchi.mp/easymedicaldevice/qms_implementation_software

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► Social Media to follow

■ Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi
■ Twitter: https://twitter.com/elazzouzim
■ Pinterest: https://www.pinterest.com/easymedicaldevice
■ Instagram: https://www.instagram.com/easymedicaldevice

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#medtech #medicaldevice #compliance

Видео QMS Implementation for MDR Up-classified Software Medical Devices канала Easy Medical Device