Lance Mason Email & Phone Number

Medical device design assurance engineer with expertise in:- electrical/electronic, mechanical, systems design qualifications- design control- product safety- design requirements- design verification- risk management- safety standards complianceSupport FDA 510K submissions, Notified Body (CE Mark) claims, and many international product registrations and challenges (China, Japan, Australia, Canada, etc.).Application and interpretation of IEC 60601-1 family safety standards including collaterals and particulars. Sponsor and coordinate NRTL (Nationally Recognized Test Lab) compliance evaluations (UL, Intertek, TUV, etc.).Applying and interpreting (EN) ISO 14971. Co-developed first FDA-accepted Safety Assurance Case for the Infusion Pump industry. Support design FMEA, Hazard Analysis, and other risk assessment activities (process FMEA, etc.).MR (magnetic resonance) conditional use qualifications (ASTM methods).Device experience: infusion pumps (ambulatory and syringe), ventilators, patient monitors, oximetry, temperature management (fluid and convective warmers), ultrahigh vacuum and surface analysis systems.

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  Saint Cloud State University

  Electrical And Electronics Engineering