Değerli Üyemiz,
AB MDR: Gereksinimler ve Uygulama ile ilgili ücretsiz Sanal Etkinlik bilgileri aşağıdadır.
Kayıt İçin : http://a4343.actonsoftware.com/acton/fs/blocks/showLandingPage/a/4343/p/p-0013/t/page/fm/0?sid=TV2:egWcRDmzg
The EU Medical Device Regulation (EU MDR) require more than a few new SOPs. A profound overhaul of the regulatory approach in one of the world’s largest medical device markets, the EU MDR demands new procedures, evidence development, documentation, relationships, reporting, data management, and a reevaluation of legacy portfolios. Senior management should be involved in strategic planning for changes that can significantly affect a company’s business.
This complimentary, four-hour virtual conference, conducted by leading experts on EU MDR requirements and implementation, provides concise insights into key aspects of the regulation to help companies understand and plan for the impending changes.
Learning Objectives:
During this event, you will learn about:
• EU MDR provisions and timeline
• Strategic considerations and priorities
• The business impact of compliance
• New clinical evidence requirements
• Changes in postmarket surveillance
• Requirements for economic operators
• Supply chain considerations
• Labeling, IFU, and UDI requirements
• Risk management provisions
• Eudamed database reporting requirements
• Remediation of legacy devices
Who Should Attend:
• Senior management
• RA/QA
• Clinical
• Postmarket
• Compliance
• Legal
• Supply Chain
• Global strategy
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