StarFish Medical
Shalaka Maind is an experienced project manager and engineer with a strong background in the medical device industry. Currently serving as a Project Manager and previously as a Project Engineer at StarFish Medical since April 2021, Shalaka has demonstrated expertise in managing projects across various organizations including Conavi Medical, Exact Imaging, and Medtronic. Notable achievements include successfully implementing the Japan Quality Management System at Conavi Medical, overseeing software and hardware development for a micro-ultrasound system at Exact Imaging, and managing validation and verification processes for a high acuity ventilator at Medtronic. Shalaka holds a Master's degree in Bioengineering and Biomedical Engineering from the University of Southern California and a Bachelor of Engineering in Biomedical/Medical Engineering from M S Ramaiah Institute of Technology.
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