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Hi welcome to my channel, This channel will help you understand 1) Operations management for any industry. 2) Regulatory affairs within the context of the medical device industry, 3) Process validation within the context of the medical device industry and any industry. 4) Quality assurance, quality control and quality management system (QMS) The regulation that is required to market a medical device in the European Union. I will help you understand the medical device regulation (MDR) 2017 745. What is needed to be compliant with this regulation for example the ISO 13485, a Quality management system, ISO 14971 and Process Validation. I will explain the In Vitro Diagnostic (IVD) Medical Device IVDR (EU) 2017 746. You will understand how to classify a medical device. How to be compliant to the European regulatory affairs. You will will understand EUDAMED, Unique device Identification (UDI) and Post market surveillance. Thank you so much. Marty

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