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About
I work at the intersection of regulatory strategy, software development, and clinical innovation, helping digital health and medical device companies bring their ideas to market.
With expertise spanning Class I–III medical devices, in vitro diagnostics, and AI-powered SaMD, I have led global submissions and designed quality management systems for FDA, Health Canada, EU MDR/IVDR and TGA requirements.
I lead regulatory operations and quality management for global corporations and also advise early-stage startups through incubator and accelerator programs.
With expertise spanning Class I–III medical devices, in vitro diagnostics, and AI-powered SaMD, I have led global submissions and designed quality management systems for FDA, Health Canada, EU MDR/IVDR and TGA requirements.
I lead regulatory operations and quality management for global corporations and also advise early-stage startups through incubator and accelerator programs.
Megan Kane is an advisor and board member based in Canada, specialising in Medical Devices. They are open to advisory board and board director opportunities and are available for introductions through Boardio.
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