Doug Shaw
Managing Principal

With over 30 years in the life sciences industry, Doug Shaw has built a career spanning laboratory science, technology compliance, and consulting. He has founded two companies and spent the past 30-plus years leading technology and compliance initiatives for medical device, biopharma, software vendors, academia, and government organizations. 
 

Doug specializes in software compliance strategies, FDA device submissions (510(k), PMA, De Novo), software development and validation, IVD project leadership, and AI/ML lifecycle implementation, helping clients navigate complex compliance landscapes. He has supported numerous FDA inspections, led digital transformation efforts, and guided organizations through gap assessments, IT governance implementation, and consent decree remediation.  
 

A contributing author to GAMP Good Practice Guides, Doug has spoken at industry conferences, led webinars, moderated panel discussions, and delivered training sessions on evolving regulatory trends. He is dedicated to advancing patient safety, strengthening data privacy, and accelerating the delivery of innovative diagnostics and treatments by ensuring that compliance and technology work together to drive progress in life sciences.​​​

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