• QARA medical devices Implementation MDR

    at Baxter International

    May 2019 - at Present


    • Acting as Quality/Regulatory/MDR subject matter experts (PMS, Supplier Quality, RA, QA, Manufacturing, Design, Marketing etc.) • Perform/Support full MDR gap analysis for Baxter/Legal Manufacturer, identify deficiencies, proposal of actions required • MDR implementation strategy, QMS process remediation, regulatory product assessment, regulatory intelligence, review MDSAP/ISO/ product certification strategy for EU and Global Markets, Review of product promotional materials, Legal Quality Agreements, Technical documentation generation • Product technical file review to MDR, CE mark Maintenance • MDR audit BSI/TUV, SwissMedic, MHRA - Notified Body/ • PMS/Vigilance activities (Complaints, FSCA, Recall, PMS system review to MDR, CER, RMP, PMS reports/PMUR, PMCF study strategy