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Navigating the FDA Approval Process for Your Software Based Medical Device

Overview

Learn from industry FDA and certification experts in the medical equipment industry as they discuss how to address the enhanced scrutiny from government agencies that can introduce significant delays with the commercial release of software-related medical devices.

During this session, FDA hot buttons affect your medical device submission will be discussed, including:

  • Requirements for software development as outlined in IEC 62304
  • Content considerations for premarket submissions
  • Human factors engineering as a platform for enhanced user safety
  • Provisions for data security and protection against unauthorized wireless access

About the Presenter

Presenter Image 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. Robertson’s 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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