Mike Russell joins SoftwareCPR as a partner

Mike Russell - Business Agility

(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.

Recent posts from Mike:  A common hurdle to achieving agile benefitsCompliance and Agile – Another Common Hurdle

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.

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 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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