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CE Mark
CE Mark
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EU MDD, IVD Directives/ MDR, IVDR Regulations: transition strategy, gap assessment, work plan and hands-on support
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Regulatory Strategy: Medical Device/ IVD/ Non Medical
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Notified Body Selection
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Product Classification
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Interactive work with Notified Bodies, Competent Authorities
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EU Technical File for CE Mark
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Materials compliance: RoHS, REACH, Cal Prop 65, EU MDR
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Clinical Evaluation Report (CER)
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Post-market Surveillance (PMS): including PMS plan, PMS report, PSUR (Periodic Safety Update Report), Post Market Clinical Follow-up (PMCF)
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Vigilance: Medical Device Reporting- FDA Medical Device Report (MDR), FSN, FSCA, Recall
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