CE Mark Certification: Compile a CE Marking Technical File (or Design Dossier for Class III) containing evidence of compliance to the Medical Devices Directive (or the IVD/AIMD Directives) - Impact of the MDR for Europe

CE Mark Certification: Compile a CE Marking Technical File (or Design Dossier for Class III) containing evidence of compliance to the Medical Devices Directive (or the IVD/AIMD Directives) - Impact of the MDR for Europe is organized by GlobalCompliancePanel and will be held from Nov 29 - 30, 2018 at Hilton Zurich Airport, Zurich, Switzerland. This CME Conference has been approved for a maximum of 12 Credits.

Description:

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
• Determine exactly which materials need to be compiled
• Completely review all existing documentation in support of meeting the applicable Essential Requirements of the Directive(s)
• Evaluate and identify gaps or deficiencies in your documentation
• Compile your EU Technical File or Design Dossier, with internal peer review
• Determine applicable testing requirements and standards for your device
• Review your clinical data, compile a Clinical Evaluation Report (CER), and facilitate a Risk Assessment as necessary
• Review your proposed labeling and Instructions for Use
• Understand what CE marking is
• Explain CE marking to others
• Understand how to demonstrate compliance
• Create a Declaration of Conformity
• Prepare a Technical File and Design Dossier
• Identify and locate all regulatory requirements and guidance documentation necessary to write procedures enabling the creation and maintenance of compliant technical files and design dossiers
• Avoid incomplete Technical Files which can result in unexpected delays or prevent market entry
• Know what is expected by Notified Bodies for technical file content during reviews and be better prepared
• An awareness of those global markets that recognize the use of STED
• An appreciation of the common pitfalls and mistakes within regulatory submissions
• Learn how the new MDR for Europe has a direct impact on the documentation going forward
• Learn how to plan for a gap assessment to transition an organization to compliance for your CER under Europe's Medical Device Regulation 2017/745

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
• Regulatory Affairs professionals
• QA/QC professionals
• Project Managers
• Compliance Officer
• Compliance Specialist
• Clinical Affairs
• Marketing & Sales Management
• Distributors/Authorized Representatives
• Legal Counsel
• Consultants
• CRO's
• RA Specialists
• Clinical Affairs/Clinical Operations personnel
• Project Leaders

Speaker: David R. Dills
Global Regulatory Affairs & Compliance Consultant and President, NovaQual

Time: 9:00 AM to 5:00 PM