Does FDA accept regulatory submissions for medical devices and SaMD that have software developed using agile methods?
What about IEC 62304 compliance? Can agile and lean approaches to software development be compliant?
On February 18th and 19th, 2019, we will explore those topics and more at our 2019 “Being Agile & Compliant” public training course. The course will be held in sunny and warm Tampa, Florida. The course will provide solid advice on compliant approaches and discuss the challenges. Our instructors are seasoned veterans, both former software engineers that delivered medical device software. Come understand the key elements for compliance and understand the intent behind US regulations and IEC 62304 and IEC/TR 80002-1.
COURSE DATES: February 18 – 19, 2019
TRAINING LOCATION: Tampa, Florida, USA
COST: 2 Full Days for $2,495.00
January Registration Discount of 10% extended through January 31, 2019. ($2,245.50)
Ask about our multi-student discount as well!
John F. Murray, Jr., recently retired from FDA and joined SoftwareCPR. John will be at the course for discussion and interaction with students!
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.
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.
- Executive Management
Considering Agile Transformation? This course will expose the challenges as well as key execution steps for success.
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.