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 is a biomedical software engineer - whatever that is! Started writing machine code for the Intel 8080 in 1983. Still enjoys designing and developing code. But probably enjoys his garden more now and watching plants grow ... and grandkids grow!

SoftwareCPR Training Courses:

Risk Management (Public or Private)

Our newly updated ISO 14971:2019 Medical Device Risk Management, A Software Organization’s Perspective training course is now open for scheduling!

  • Coverage of ISO 14971:2019, IEC 62304; amd1, and IEC/TR 80002-1.
  • System level hazards analysis – mapping to software, cybersecurity, and usability
  • Why FMEA is incomplete for medical device risk management.
  • How to perform software hazards analysis.
  • And more!

3-days onsite with group exercises, quizzes, examples, Q&A.

Instructors: Dr. Peter Rech, Brian Pate

Next public offering:  TBD


Being Agile & Yet Compliant (Public or Private)

Our SoftwareCPR unique approach to incorporating agile and lean engineering to your medical device software process training course is now open for scheduling!

  • Agile principles that align well with medical
  • Backlog management
  • Agile risk management
  • Incremental and iterative software development lifecycle management
  •  Frequent release management
  • And more!

2-days onsite with group exercises, quizzes, examples, Q&A.

Instructors: Mike Russell, Ron Baerg

Next public offering:  TBD


Medical Device Cybersecurity (Public or Private)

This course takes a deep dive into the US FDA expectations for cybersecurity activities in the product development process with central focus on the cybersecurity risk analysis process. Overall approach will be tied to relevant standards and FDA guidance documentation. The course will follow the ISO 14971:2019 framework for overall structure but utilize IEC 62304, IEC 81001-5-1, and AAMI TIR57 for specific details regarding cybersecurity planning, risk characterization, threat modeling, and control strategies.

2-days onsite with group exercises, quizzes, examples, Q&A.

Instructor: Dr Peter Rech, 2nd instructor (optional)

Next public offering:  TBD


IEC 62304 and other emerging standards for Medical Device and HealthIT Software (Public or Private)

Our flagship course for preparing regulatory, quality, engineering, operations, and others for the activities and documentation expected for IEC 62304 conformance and for FDA expectations. The goal is to educate on the intent and purpose so that the participants are able to make informed decisions in the future.  Focus is not simply what the standard says, but what is meant and discuss examples and approaches one might implement to comply.  Special deep discount pricing available to FDA attendees and other regulators.

3-days onsite with group exercises, quizzes, examples, Q&A.

Instructor: Brian Pate, 2nd instructor (optional)

Next public offering:  TBD


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