(March 1, 2021)— Mike Russell has joined Crisis Prevention and Recovery LLC (DBA SoftwareCPR ®) as a Partner. He is not new to the firm and industry, having assisted on many engagements in the last decade as an Affiliated Expert. He was also on the TIR working group that created the AAMI TIR45- 2012 Technical Information Report Guidance on the use of Agile practices in the development of medical device software.
Mike is an expert in business agility and is key contributor to SoftwareCPR’s “agile and compliant” process transformation and improvements. He combines experience serving as a C-level executive, including as Chief Operations Officer for a top 50 U.S. bank, and as a management consultant and trusted advisor to CEOs and other top executives at diverse organizations in multiple industries. This has provided him with first-hand experience dealing with many opportunities and challenges facing executives today, especially with rapid change and digital transformation. He documented some foundational principles and a roadmap for putting them into action in his book Wrong Until Right – How to Succeed Despite Relentless Change.
As a partner at SoftwareCPR he looks forward to continuing to share his expertise with industry through consulting, coaching, and training. For more information click softwarecpr.com or call 781-721-2921.
About SoftwareCPR®: The firm is best known for software, regulatory, risk management, validation, and 21 CFR Part 11 consultation for medical device, pharmaceutical, and blood establishment computer system manufacturers. SoftwareCPR® also provides full FDA enforcement action crisis recovery, premarket submission, and quality system training and consulting services with a focus on client culture, business goals, and efficiency as well as device safety and effectiveness.