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.
CE Mark Certification: Compile a CE Marking Technical Filecontaining evidence of compliance to the Medical Devices Directive Impact of the MDR for Europe 2018 covers topics such as:
- 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
CE Mark Certification: Compile a CE Marking Technical Filecontaining evidence of compliance to the Medical Devices Directive Impact of the MDR for Europe 2018 brings together:
- 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
