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CE Mark

  • Regulatory Strategy- Medical Device/ IVD/ Non Medical

  • Notified Body Selection

  • Product Classification

  • Interactive work with Notified Bodies, Competent Authorities  

  • EU Technical File for CE Mark

  • Materials compliance: RoHS, REACH, Cal Prop 65, EU MDR

  • Clinical Evaluation Report (CER)

  • Post-market Clinical Plan 

  • Vigilance: Medical Device Reporting- MDR, FSN, FSCA, Recall

  • EU MDD, IVD Directives / MDR, IVDR Regulations: transition strategy, gap assessment, work plan and hands-on support