Rory Carrillo

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I run a consulting firm that provides medical device design, development, quality system implementation, and global regulatory services as well as technical feasibility assessments, product viability assessments, new technology research, and clinical study and usability study guidance and implementation, and clinical evaluations for EU. We provide project management services to ensure that you develop your product in compliance with quality standards and regulatory standards. We have an extensive background in intravascular imaging, cardiovascular therapies, OCT imaging, wearable devices, women's health, cloud-based software imaging products, deep-learning technologies and more. We have intimate knowledge of medical device development for Class 2 & Class 3 devices conforming to 60601-1 2nd and 3rd edition while maintaining compliance with 21 CFR 820, ISO 13485 regulations, IEC 62304, and IEC 62366 standards. Extensive experience working with, managing, and leading 3rd party development partners. Experience in both startup and corporate environments.

In addition, my firm partners with some of the industries leading experts focusing on market research and reimbursement, IP legal services, and connects startups to some of the world's leading physicians spanning many different specialties.