David has a background in Software Engineering and has 26+ years of experience developing and validating Medical Devices. He currently is an Associate Software Director for Boston Scientific Neuromodulation.  His responsibilities include managing all aspects of software development and validation including security risk.  In addition, David is a faculty member at AAMI and has been developing and instructing courses for more than 12 years.

Jeremy Jensen is a Fellow Software Quality Engineer in the corporate global software steward group of Boston Scientific. Currently he responsible for establishing and maintaining effective structures to ensure consistent implementation of quality systems as it relates to regulated software at Boston Scientific. He helps create and implement processes and process improvements to ensure consistent implementation of external regulated software laws, regulations, guidance’s and standards (LRGS).

Mike Russell is a Partner with SoftwareCPR®. He provides services such as Quality Management System assessments and efficiencies, regulatory filing assistance, development process improvements, and leadership coaching and training. He is an expert in business agility and “agile and compliant” process transformation. Mike served 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 combines expertise serving as both a C-level executive, including as Chief Operations Officer for a top 60 U.S. bank, and as a trusted advisor to CEOs and other top leaders at diverse organizations in multiple industries. This has provided him with first-hand experience dealing with many opportunities and challenges facing leaders today, especially with rapid change and digital transformation. For example, while leading a product division, Mike introduced changes that resulted in improved productivity by 15%, cut time-to-market by up to 67%, and reduced defects by over 50% in flagship products processing of over $80 billion in financial transactions per year.

His experiences cover 48 U.S. states, Puerto Rico, U.S. Virgin Islands, and 20+ countries. He has spoken internationally and written on many subjects, including transformation and business agility, in his book Wrong Until Right – How to Succeed Despite Relentless Change. He also has been a reviewer for other authors’ books and publications. He has taught at both undergraduate and graduate levels and was a Lean Startup Week mentor.

Mr. Mark Walker is a consultant and owner of Walker Validation and Compliance Services located in Southwest Florida.  Walker Validation and Compliance Services (WVCS) provides consulting services to Medical Device, Pharma and Biotech industries involving FDA's Quality System Regulation and ISO Quality Management system (ISO 13485).  Mr. Walker’s industry experience includes, IVD, cardiovascular, orthopedics, plasma collection and processing, surgical devices, convenience kits, various medical device software manufactures, OTC drug manufacturing, bulk drug manufacturing, and large biotech.  Services include regulatory compliance, computer systems validation, medical device software development life cycle, software and production equipment qualification, quality management system (QMS) auditing, QMS development, QMS training, risk management, and 21 CFR Part 11 compliance (Electronic Records and Electronic Signatures).  Mr. Walker has more than 25 years of experience in providing project management, consulting, training, regulatory compliance and business development services.
Mr. Walker has been an instructor for the Association for the Advancement of Medical Instrumentation (AAMI) since 2012 which develops training and guidance with FDA for the use of medical devices.  He currently serves on AAMI Medical Device Software Committee.  Mr. Walker was a contributing author for The Quality System Compendium: CGMP Requirements and Industry Practice, Fourth Edition and also co-authored “Risk Management Tools” (Chapter 2) in the book “Risk Management Applications in Pharmaceutical and Biological Products Manufacturing”, published by John Wiley & Sons, Inc.
Mr. Walker has a Bachelor of Science degree and an Associate of Engineering degree in chemical engineering technology.  In his free time, he volunteers with county emergency rescue service agencies providing technical rescue, emergency medical services and computer systems support.