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CE Mark 

CE Mark

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

  • 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 Surveillance (PMS): including PMS plan, PMS report, PSUR (Periodic Safety Update Report), Post Market Clinical Follow-up (PMCF)

  • Vigilance: Medical Device Reporting- FDA Medical Device Report (MDR), FSN, FSCA, Recall

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