Format: The course format will consist of lecture with in-class or group exercises to maximize learning.
Target Audience: Instruction is targeted to professionals involved in medical device software development such as those in software design and testing, quality assurance, compliance, quality systems, and product development management.
Prerequisite: AAMI recommends this course for professionals who already have a basic understanding of the framework of quality management systems, but need more in-depth information about the concepts, processes, and practical applications of agile practices. It is recommended that personnel who are new to the medical device industry have working knowledge of the Quality System Regulation; therefore AAMI recommends our
Quality System Requirements and Industry Practice and
Regulatory Requirements for Software Validation in the Medical Device Industry courses as prerequisites.
Trainers:
- Kelly Weyrauch, Owner, Agile Quality Systems LLC
- Brian Lewis Pate, Partner, SoftwareCPR®
- FDA - John Murray, FDA, (Via Teleconference)
Registration Fees:
- AAMI Members $2135
- Nonmembers $2435
- Government employees $750
Materials: Includes electronic versions of the following:
Meals: Includes breakfast, lunch, and refreshments. Complimentary Wi-Fi Internet access will be available in the meeting area.