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Mike Morton has over thirty years of regulatory, clinical and quality experience in the medical device industry, including serving as Vice President for Corporate Regulatory Affairs at Medtronic, on the Board of Directors for the Regulatory Affairs Professionals Society, and serving on FDA and other regulatory body working groups . In this episode we explore regulatory pathways for devices in the US, Europe and other countries, building relationships with regulators, how things have changed with regulatory agencies worldwide, where companies are launching first and why, what a regulatory affairs professional does throughout the product life cycle, and the importance of regulatory strategy.
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