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

Partner and General Manager, Brian Pate is ISO 1385:2016 Lead Auditor certified for Medical Device Quality Management Systems (MD), and ISO 19011:2018 Management Systems Auditing (AU) and Leading Management Systems Audit Teams (TL). Brian started his medical device career in anesthesia clinical research in 1985 and has since worked both academia and industry including many years with Johnson & Johnson, Baxter Healthcare, and GE Medical. Brian’s roles have included software engineering, systems engineering, quality assurance, and regulatory affairs. Brian has served on multiple AAMI TIR working groups, including TIR32-2008 (Application of ISO 14971 Risk Management to Software; now IEC 80002-1) and TIR45-2012 (Guidance on the use of Agile practices in the development of medical device software) and served as a reviewer for the 2nd edition of TIR45. Brian serves on the AAMI Software Committee and as an AAMI instructor for the software, design controls, and agile methods courses. Brian also is a member of the Underwriters’ Laboratories (UL) Standards Technical Panel for UL1998 (Software in Programmable Components) and or UL5500 (Remote Software Updates).

SoftwareCPR Training Courses

ISO13485:2016 ISO 13485 Internal Audit(or) Training Course (Live, 3-day)

IEC 62304 and other Emerging Standards Impacting Medical Device Software (Live, 3-day)

Being Agile & Yet CompliantISO 14971 SaMD Risk Management

Software Risk Management

Medical Device Cybersecurity

Software Verification

IEC 62366 Usability Process and Documentation

Or just email training@softwarecpr.com for more info.

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Partners located in the US (CA, FL, MA, MN, TX) and Canada.