Software Development for Medical Device Professionals

This one and a half day course will be most valuable to medical device engineers, engineering managers, regulatory affairs professionals, 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, 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 software development, software design control procedures and will include software development models and regulatory strategy. The second day will discuss the practical aspects of creating and managing the software development program.

Course Description

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.

Among the topics to be discussed: Context of software development within the overall quality system and regulation (QSR), software related procedures, forms, records, safety/risk management strategies, documentation strategies, software evolution strategies, and strategies for integrating the general quality system procedures into the software development program.