George Stone Email and Phone Number

Developed and manage the company QMS; developed and maintain the project DHF for the Soovu Labs Wearable Heatwave Therapy device, and all corresponding documentation (requirements, design specs, design reviews, risk management file, usability engineering file, supplier assessments, calibration log, etc); Work with Mfg Engineer and manufacturer to develop tools qualification procedures and tests for those tools developed by Soovu Labs. Manage UDI and UPC labeling for products and registrations in applicable databases; conducted 513(g) request for FDA input on product's device classification; registered product with FDA. Co-developed post-production feedback plan and complaint handling mechanism.

Initiated collaborative reorientation of EE, ME, and SWE groups towards a design and development process that is more in line with required quality system processes (ISO 13485) in software development (IEC 62304), usability engineering (IEC 62366), electrical and mechanical safety (IEC 60601-1), safety risk management (ISO 14971), and supplier quality per 13485. Managed Safety Risk Plan and Analysis of the new generation of Philips Advanced Life Support Monitor/Defibrillator. Reviewed and assessed multiple adverse event reports, analysed associated potential trends and provided report to clinical manager.

Hired, trained, and led the QE group in defining medical device specifications for software, electrical, mechanical, safety risk, and usability in collaboration with respective engineering groups; developed corresponding test plans and procedures to qualify medical devices before transfer to manufacturing. Developed QE proposals for new product development including time, resources, and delivered product.Consulted with clients regarding applicable regulatory requirements and standards that applied to their product; Member of AAMI, local RAPS organization.