This Event has Passed
Thursday, November 29, 2018
9:00 AM - 6:00 PM
9:00 AM - 6:00 PM See all dates and Times
https://www.globalcompliancepanel.com/control/globalseminars/~product_id=901864SEMINAR?upcomingevents-NOV-SEO-2018
Why you should attend Introductions and overview of the EU Directives Identify the EU Directives and standards applicable to your product Comply with the implementation details and requirements of the EU MDR & IVDR
Design a new product, or evaluate an existing product, for conformity with these Directives and standards
Conduct and document a detailed Hazard Identification and Risk Assessment of your product
Complete the necessary Technical File and documentation required to meet EU legal requirements
Understand the relationship between CE Marking requirements
Who will benefit:
Personnel who want to know all aspects of the CE Mark, Technical File and Design Dossier and the impact from the new MDR for EU. Medical device professionals in areas of Quality and Regulatory Affairs, design, risk management, postmarket activities, R&D, and manufacturing, who work for manufacturers that market devices in the EU. Employees and personnel who will benefit include:
All levels of management and departmental representatives any anyone who desire a better understanding or a 'refresh' overview of MDD/AIMDD/IVDD and compiling the documentation
Senior Management
Regulatory Affairs Managers and RA SME's
QMS Compliance personnel
Quality Managers
Design, Development, Manufacturing and Marketing Managers
Auditors
Risk Management
Design a new product, or evaluate an existing product, for conformity with these Directives and standards
Conduct and document a detailed Hazard Identification and Risk Assessment of your product
Complete the necessary Technical File and documentation required to meet EU legal requirements
Understand the relationship between CE Marking requirements
Who will benefit:
Personnel who want to know all aspects of the CE Mark, Technical File and Design Dossier and the impact from the new MDR for EU. Medical device professionals in areas of Quality and Regulatory Affairs, design, risk management, postmarket activities, R&D, and manufacturing, who work for manufacturers that market devices in the EU. Employees and personnel who will benefit include:
All levels of management and departmental representatives any anyone who desire a better understanding or a 'refresh' overview of MDD/AIMDD/IVDD and compiling the documentation
Senior Management
Regulatory Affairs Managers and RA SME's
QMS Compliance personnel
Quality Managers
Design, Development, Manufacturing and Marketing Managers
Auditors
Risk Management
