Being Agile and Yet Compliant Training Course – Dec 2022

Registration now for our next “Being Agile and Yet Compliant” Training Course.  Our fall offering is coming up.  Conveniently scheduled to work across many timezones!

COURSE DATES: December 12-15, 2022 (16 hours of training)

HOURS:  11 am until 3 pm EDT each day
TRAINING LOCATION: Virtual – live online

COST: 4 half days for $1,920 per person

$200 discount per student when registering 3 or more.

Registration Link:

Only a limited number of early bird registration seats are available.  Register using the link above.

  • 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 16 hour course will be taught by SoftwareCPR® partners Mike Russell and Ron Baerg.

Mike was a member of the AAMI working group that developed TIR45 Effective Application of Agile Practices in the Development of Medical Device Software.  Ron is a current member of the AAMI working group working on the 2nd edition of TIR 45. Full credentials on our website:

Who Should Attend?

  • Quality Assurance and Regulatory Affairs professionals
  • Product Owners
  • Scrum Masters/Coaches
  • Software development managers and engineers
  • Risk management owners
  • Test engineers

This course will provide a clear understanding of requirements versus areas of flexibility and provide ideas and suggestions to use for gap analysis, auditing, and software vendor and OEM qualification and management as well as improving articulation and defense of your approaches to regulatory bodies, internal quality assurance, and regulatory affairs departments.

Training Location

Virtual course delivered by Zoom.

For more information

About the author

Allison joined SoftwareCPR in 2022, bringing along over ten years of passion for building teamwork and growth in organizations. This is established in part by the greatest University the South has to offer- Mississippi State.

Upcoming SoftwareCPR Training Courses:

Public Course – Jan 9-11, 2023 – Risk Management (in-person)

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

Where:  Tampa, Florida

  • 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

Discount Registration through October 31, 2022.  Reserve your spot!

Register here:–iso-14971-medical-device-risk-management-a-software-organizations-perspective-2138576610


Public Course – Dec 12-15, 2022 – Being Agile & Yet Compliant (virtual)

COST: 4 half days for $1,920 per person

HOURS: 11 am until 3 pm EDT each day

TRAINING LOCATION: Virtual – live online

Register here:


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