StarFish Medical
Alexandra (Sandy) Reid is a seasoned QA/RA Specialist at StarFish Medical since November 2017, where expertise in regulatory compliance and conformance standards aids clients in navigating ISO 13485 regulatory requirements. In a previous role as a Proposal Writer at StarFish Medical, Alexandra transformed client concepts into actionable plans. Prior experience includes serving as a Research & Innovation Development Officer at the Natural Sciences and Engineering Research Council of Canada, promoting Research Partnership Programs, and evaluating grant applications. Additionally, Alexandra worked as the Director of Business Development at Mitacs Inc., advocating for funding programs, and as a Visiting Research Postdoctoral Fellow at Agriculture & Agri-Food Canada, focusing on recombinant therapeutic proteins. Educational qualifications include a Ph.D. in Plant Molecular Biology from the University of Calgary, an MSc in Plant Physiology from the University of Guelph, and a B.Sc.(H) in Biology from Queen's University.
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StarFish Medical
StarFish Medical provides award-winning design, development, and flexible manufacturing outsourcing services —100% dedicated to the medical device and life science marketplace. StarFish partners with innovative companies to create and manufacture breakthrough products for a full range of medical specialty areas including: Cardiovascular, Digital Health, IVD, Ophthalmology, Optics, Ultrasound, POC Assay Diagnostic Technologies, and Microfluidics. StarFish expertise includes electronics, mechanical, human factors and software systems engineering. Our proprietary Pathfinder™ process for medical device product definition saves clients time and resources throughout the technology and product development phases to commercialization. Prototype and low volume complex electro-mechanical production are delivered in ISO 13485 certified facilities with cleanroom capabilities in Toronto and Victoria Regulatory and quality system (QMS) consultants at StarFish provide technical regulatory assistance for FDA and Health Canada submissions, including IEC 60601 and ISO13485. Innovative Design and Development Electronic / software / mechanical engineering Industrial design / human factors engineering PathfinderTM product definition process Technology optimization Verification / validation / testing ISO 13485 certified QMS Integrated Manufacturing Seamless ramp from clinical trials to full production Deep engineering involvement & oversight Electro-mechanical / software expertise Customized cart specialists Optical instrument build and test Dedicated program manager Flexible Manufacturing New product introductions Supply-chain management North America facilities Depot repair & field service Sustaining / value engineering Class 100,000 cleanroom