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