EdgeOne Medical was founded in 2012 as a result of a simple observation: in the Medical Device and Combination Product development ecosystem there was a lack of external service providers for Device Manufacturers who could provide the integrated services of project management, product verification & validation testing, quality, and regulatory in an ISO 13485 certified lab. This market deficiency led Lilli Zakarija to create the vision for the EdgeOne Medical services offering and the capabilities to achieve it. With our pragmatic, get only what you need, complementary services, medical product developers can more effectively plan and execute product development within the guardrails of regulatory compliance and quality system adherence. EdgeOne is, after all, on a mission to give all medical product developers an edge, one successful product development and management program after another.
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