Navigating the FDA Approval Process for Your Software Based Medical Device


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Learn about the design control requirements and product development approach that can shorten your medical device's path to market with a focus on safety, human factors engineering and security.

Meet the speakers

Steve Robertson

President, Steve Robertson Consulting

Steve Robertson is President of Steve Robertson Consulting, LLC, a consulting company focused on assisting client companies with quality management system rescue and repair. Prior to entering the field of medical device consulting, Mr. Robertson served as a Vice President of Quality for a number of major medical device companies, including Baxter International, Fenwal Inc., Covidien, and St. Jude Medical. Mr. Robertsons 26-year medical device experience includes the development and implementation of FDA-compliant quality systems that have allowed multiple companies to resolve FDA Warning Letters and restore their freedom to operate in the US and international markets. He has led multi-national quality organizations in the development and implementation of quality system solutions for diagnostic devices, infusion pumps, blood collection, separation and storage devices, vascular therapies, implantable neuromodulators, surgical instrumentation, and joint replacement technologies. Mr. Robertson received a BS degree in Engineering from the United States Military Academy at West Point, and an MBA from the University of Dallas.


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