Specialties:
Expertise in Device Software, Complex Systems and Single-use Disposables (Catheters, Ultrasound, RF, Minimally Invasive Surgery MIS, Microwave, Laser) Regulatory Affairs Publishing - 510(k), IDE, PMA, Technical File (TF), Design Dossier (DD) Risk Analysis/Risk Management (FMEA, FMECA, HA, ISO 14971) Auditing (Supplier, Internal, Gap Analysis, QSR, QSIT, ISO 13485, MDD)
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