The Center for Professional Innovation & Education, Malvern, PA
10/1/08
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.
Learning Objectives
Upon completion of this course, attendees 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 discussing cost-effective techniques that meet the regulations. The first day will cover topics including relevant regulations, guidance documents and standards, interpreting design controls for software development, and software development lifecycle models. The second day will discuss risk management and software verification and validation.
Course Description
This continually updated course covers current FDA regulatory compliance with respect to developing medical device software. A focus will be placed on the Quality System Regulation (QSR), FDA guidance documents and relevant international standards. Among the topics to be discussed: Software development within the context of Design Controls, software procedures and records, risk management for software-based devices, documentation requirements, and verification and validation techniques.
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