COURSE DATES: February 18 – 19, 2019
TRAINING LOCATION: Tampa, Florida, USA
COST: 2 Full Days for $2,495.00
January Registration Discount of 10% available through Jan 19, 2018.
Meet our newest partner, John Murray, at the course!
Only a limited number of discounted seats are available – download registration form and email to firstname.lastname@example.org. For more information on the course, use the form below.
- Our course is framed around IEC 62304 and how the standard can be used to ensure agile methods and approaches to software development.
- Discuss the proper activities and deliverables for safe and effective software.
- Uses concepts from AAMI TIR45 as well to help communicate how agile methods can, when used properly, improve software quality.
- Reference US regulations and FDA guidance to address potential gaps that can occur with some agile approaches.
- Understand how backlog management, development iterations, and release cycles can easily align with the intent and expectations of regulators and auditors.
- Discussion on tools and the very important role they MUST play in the effective use of agile methods for medical device and digital health software.
- Integrated exercises designed to apply learning!
This 2 day course will be taught by Brian Pate and Ron Baerg of SoftwareCPR®.
Brian was a member of the AAMI working groups that developed TIR32 Medical Device Software Risk Management and TIR45 Effective Application of Agile Practices in the Development of Medical Device Software. Brian currently is the lead faculty for the AAMI Regulatory Requirements for Software Validation course and is co-faculty for the AAMI Agile course. Ron has over 23 years in developing medical device software for many levels of safety risk. Full credentials on our website: www.softwarecpr.com
Who Should Attend?
Quality Assurance and Regulatory Affairs professionals. This course will provide a clear understanding of requirements versus areas of flexibility and provide checklists and questions to use for gap analysis, auditing, and vendor and OEM qualification and management.
Product Owners, Scrum Masters/Coaches, software development managers/engineers, risk management, and test engineers. This course provides examples, checklists, and partial templates as well as improving articulation and defense of your approaches to regulatory bodies, internal quality assurance, and regulatory affairs departments.
Center for Advanced Medical Learning and Simulation (CAMLS). As one of the world’s largest, free-standing centers fully dedicated to training healthcare professionals, the 90,000-square-foot, three-story facility provides a state-of-the-art, clinical environment with 60,000 square feet dedicated to surgical skills labs, operating suites, a virtual hospital and simulation center, and more than 25,000 square feet of dedicated education and conference space. Conveniently located in the heart of downtown Tampa, FL, it is open 7 days a week to accommodate the numerous demands that challenge today’s healthcare providers and researchers as well as its numerous international clients.
Several hotels are within 1 or 2 city blocks of CAMLS. No rental car is needed as many restaurants, shopping and entertainment are easily accessible in the Tampa Riverwalk and Channelside district.