CE Mark Certification: Compile a CE Marking Technical Filecontaining evidence of compliance to the Medical Devices Directive Impact of the MDR for Europe 2018

CE Mark Certification: Compile a CE Marking Technical Filecontaining evidence of compliance to the Medical Devices Directive Impact of the MDR for Europe 2018 is a conference dedicated to understand the relationship between ce marking requirements.

Topics

• The EU Directives and standards applicable to your product
• Introductions and overview of the EU Directives
• A new product, or evaluate an existing product, for conformity with these Directives and standards
• The implementation details and requirements of the EU MDR IVDR
• The necessary Technical File and documentation required to meet EU legal requirements
• And document a detailed Hazard Identification and Risk Assessment of your product
• Exactly which materials need to be compiled
• The relationship between CE Marking requirements
• And identify gaps or deficiencies in your documentation
• Completely all existing documentation in support of meeting the applicable Essential Requirements of the Directive(s)
• Applicable testing requirements and standards for your device
• Compile EU Technical File or Design Dossier, with internal peer review
• Your proposed labeling and Instructions for Use
• Your clinical data, compile a Clinical Evaluation Report (CER), and facilitate a Risk Assessment as necessary
• CE marking to others
• What CE marking is
• A Declaration of Conformity
• How to demonstrate compliance
• And locate all regulatory requirements and guidance documentation necessary to write procedures enabling the creation and maintenance of compliant technical files and design dossiers
• A Technical File and Design Dossier
• What is expected by Notified Bodies for technical file content during reviews and be better prepared
• Incomplete Technical Files which can result in unexpected delays or prevent market entry
• An appreciation of the common pitfalls and mistakes within regulatory submissions
• An awareness of those global markets that the use of STED
• How to plan for a gap assessment to transition an organization to compliance for your CER under Europe`s Medical Device Regulation 2017/745
• How the new MDR for Europe has a direct impact on the documentation going forward

Who should Attend

• Senior Management
• 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
• QMS Compliance personnel
• Regulatory Affairs Managers and RA SME`s
• Design, Development, Manufacturing and Marketing Managers
• Quality Managers
• Risk Management
• Auditors
• QA/QC professionals
• Regulatory Affairs professionals
• Compliance Officer
• Project Managers
• Clinical Affairs
• Compliance Specialist
• Distributors/Authorized Representatives
• Marketing & Sales Management
• Consultants
• Legal Counsel
• RA Specialists
• CRO`s
• Project Leaders
• Clinical Affairs/Clinical Operations personnel