Following the success of the Symposium in Prague in 2016 and in Berlin in 2017, this third Symposium will address the important updates for Medical Devices.
In conjunction with EAAR (European Association of Authorized Representatives), our excellent panel of experienced professionals in this field will once again ensure a symposium of noteworthy quality.
Topics to be covered, among others will be:
- Implementation of the New Regulations
- The Road to 2020: Overview of Regulatory Developments
- Major Regulatory Compliance Challenges for the Industry
- Challenges for National Competent Authorities
- New Legal Challenges to the Medical Device Industry
- Scope, Borderlines and Classification
- General Safety and Performance Requirements
- Practical Aspects of Clinical Evaluation: What needs to be updated now and how to plan for Future Compliance under the MDR
- Impact of the MD/IVD-Regulations on Quality Management Systems
- View of a Notified Body on the MDR Implementation Steps
- Post-Market Surveillance
- Do you need to plan for PMCF and What are the Possibilities for Gathering PMCF Data?
- The Impact of Increased Transparency and Traceability Resulting from Eudamed and the Introduction of UDI
- What can we Expect from the MDR Authorized Representative?
- Special IVD Issues
- Conflicts Between Economic Operators
These topics will be updated further upon completion of the agenda.
Join the RMD2018 Symposium and benefit from expanding your network.