WEBINAR | Quality Management Systems: MDR and IVDR impact

WEBINAR | Quality Management Systems: MDR and IVDR impact

Regulations EU/20174/745 (Medical Device Regulation- MDR) and EU/2017/746 (In Vitro regulation- IVDR) bring requirements for Quality Management Systems. Article 10 requires manufacturers to have a QMS that covers “all parts and elements” of their organization, addressing the quality of their products, as well as of their procedures and processes.


During this webinar, essential aspects that Quality Management System must meet to comply, both with ISO13485:2016 and MDR and IVDR will be discussed.

DATE: 14/6/2021

TIME: 2:00- 2:45 p.m. CEST

SPEAKER: Talyta Carteano, Medical Device Manager


You can register here:



☑️ Also, in case you would like to know more or need further assistance, you can schedule a free 30 minutes consultation meeting at the Medical Devices calendar here:



➡️ You can also contact us at: info@asphalion.com


We will be more than happy to help you!


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