The Center for Professional Innovation & Education, King of Prussia, PA
December 8 & 9, 2010
Who Should Attend
This two-day course will be most valuable to medical device software engineers, engineering managers, scientists, and quality engineers (particularly in product development). This course will also be of benefit to quality assurance and regulatory affairs personnel who are new to the industry or their current position and do not have an in-depth knowledge of Medical Device Software requirements.
The program also provides an opportunity for more experienced personnel, including middle and upper management, to update and broaden their knowledge of the FDA’s software development requirements.
Upon completion of this course, you will have gained an understanding of how to effectively meet the requirements of software development design control for medical devices. Particular emphasis will be placed on effective design strategy, as all too often unnecessary time and money is spent on ineffective software design control processes.
The first day will cover topics including regulations and standards, software development, software development procedures and will include software development models and design controls. The second day will discuss software validation of development tools and software used in Manufacturing and throughout the Quality System as well as risk management for software-based medical devices.
Several interactive exercises are used to reinforce principles and concepts.
This continually updated course covers current FDA regulatory compliance with respect to developing medical device software. A focus will be placed on both the regulation and FDA’s supplemental guidelines.