Companies in multiple industries have found that agile methods improve their software development by increasing predictability of software releases, allowing more flexibility in responding to user needs, lowering costs, and improving overall software quality.
In spite of these proven advantages, these methods have not been widely adopted in the highly regulated medical device industry. Medical device companies can take advantage of the many long-lasting benefits of agile methods if they understand how to integrate them properly into a regulated environment.
June 9 9:30am PST
Kelly Weyrauch, Principal Consultant at Agile Quality Systems, LLC and author of the AAMI TIR:45 guidance
Kelly has more than 30 years of software and systems development experience, and 20 years of focus on software processes and quality systems for medical devices. As one of the principal authors of AAMI TIR45 Guidance on the use of AGILE practices in the development of medical device software, Kelly has worked with the FDA and industry leaders on the application of Agile practices to the medical device world.
Aaron Joseph, Senior Medical Device Consultant for Consensia
Aaron is an avid promoter of lean and agile methods and helps clients to efficiently comply with regulatory requirements for software and hardware development. He works closely with product development teams in performing risk analyses, planning V&V testing, managing product requirements, refining design control procedures, and training R&D staff. Aaron has extensive experience with design verification and validation, including software, hardware, and system testing.
Maren Nelson, Medical Device Development, Quality System, and Regulatory Specialist at M Nelson Consulting
Maren is an experienced professional in the use of risk management to create and improve processes, as well as the development and regulatory approval of medical devices through the entire product life-cycle. She have experience in process improvement and training from R&D and Quality perspectives. She is PMP certified.