Can Agile Methods be used for Medical Devices?

CAMLS Tampa FL Agile medical device

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

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!

Download registration form

Only a limited number of discounted seats are available – download registration form and email to  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:

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.

Training Location

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.

For more information

About the author

Brian Pate helps medical device companies achieve efficient and FDA regulatory compliant product development to produce higher quality and clinically valued software. He began his career in clinical research in 1985 with the Department of Anesthesiology at UAB developing closed-loop control systems for the automated delivery of gases and control. In 1990, he made the switch from university research to the medical device industry designing control systems, communication interfaces, user interface, and other software for real-time embedded systems and clinical information systems, working for medical device companies including Johnson & Johnson, Baxter Healthcare, and GE Medical. Today, he is a Partner and the General Manager of Crisis Prevention and Recovery LLC (dba SoftwareCPR®), a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software. He has taught the AAMI/FDA course on Software Regulation to FDA Reviewers at FDA and is currently the lead faculty for the public version of that course taught annually along with FDA staff. Brian served on the AAMI/FDA TIR working group that created AAMI TIR32 Guidance on the application of ISO 14971 to Software (later superseded by IEC 80002-1). He later served on the original AAMI/FDA working group that created the AAMI TIR45-2012 TIR Guidance on the use of Agile practices in the development of medical device software and is currently the co-chair leading the creation of the 2nd edition of TIR45. He has served as faculty for all offerings of the AAMI/FDA Compliant Use of Agile Methods public course. Brian also served as an instructor for the AAMI Design Controls course. He is also a member of the Underwriters’ Laboratories Standards Technical Panel 5500, Remote Software Updates. He now serves as a member of the AAMI Software Committee.

Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

Interested in having a conversation?  Email us to arrange a Zoom meeting or call us at +1 781-721-2921.

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15148 Springview St
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