Getting Your Medical Device FDA Approved
Join Mentor Embedded for a free lunch or dinner and hear 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. Getting through the FDA review as quickly as possible requires a clear understanding of the development standards, documentation and testing that is now expected for 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
This interactive discussion will review 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. Lunch or dinner will be served at each of the two sessions. After submitting your interest, a member of our team will be in touch to register you for the event and provide additional details.
About the Presenters
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.
Mr. Romanski has specialized in the production of software development environments for the past 35 years. His work has focused on compilers, cross compilers, run-time systems, and tools for embedded real-time applications. Since 1992, he has concentrated on software for safety critical applications and safety critical verification.
Andrew Caples is a product marketing manager for the embedded systems division of Mentor Graphics. He has over 20 years of experience in start-ups and fortune 500 high tech companies and has served in a variety of roles ranging from technical marketing to sales management. He has a B.S. in Electrical and Computer Engineering from California Polytechnic University. His current responsibilities include product management for the Nucleus Real Time Operating System.