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1.Regulatory Requirements according to MDR

  • Introduction: Importance of clinical data for Medical Device manufacturers
  • Workshop: Understanding the requirements of the new Medical Device Regulation incl.:  

               -Clinical Evaluation

               -Post-market clinical follow-up (PMCF)

        -Interface to post-market surveillance (PMS)

  • Summary: Activities required for Implementation of MDR requirements        

2. Execution of a clinical Evaluation acc.to MEDDEV 2.7/1, Rev.4

  • Workshop: Design of processes for:                                                        - Initial creation and update of the clinical Evaluation                                                                                                 - Interfaces to development, Risk management, post-market surveillance 
  • Workshop: Creation of templates for content of: 

       -Clinical Evaluation Plan (CEP)                                                                                                                                                 -Clinical Evaluation Report (CER)

  • Discussion: Effective data exchange between clinical Evaluation and post-market surveillance records




Package and Fees:

Certificates

Trainings Materials PDF and Hardcopy

Catering

CHF 700 excl.taxes

Group of Participants:

Medical Device Manufacturers


Attendees

Reduction

3 to 5 Attendees

20% off (3.-5.attendees)

6 to 10 Attendees

25% off (6.-10.attendees)