ABOUT HOPESTONE
Trusted QRA Partner for IVD and Medical Device Companies
Hopestone Capital and Consulting provides senior-level Regulatory Affairs and Quality Assurance support for companies navigating complex compliance, audit, and product lifecycle challenges. We help organizations strengthen quality systems, clarify regulatory strategy, prepare for inspections, and turn complex requirements into practical execution.
25+
Years of IVD and Medical Device Experience
10k+
Products Supported Globally
David G. Davis
Founder & Principal Consultant
David G. Davis is the Founder and Principal Consultant of Hopestone Capital & Consulting, LLC, bringing more than 25 years of MedTech and IVD Quality Assurance and Regulatory Affairs leadership experience. He has led global regulatory strategy, quality governance, product lifecycle oversight, post-market programs, and regulatory transformation initiatives across the U.S., E.U., China, India, LATAM, METAM, and APAC markets.
David’s background includes senior executive leadership for large global organizations supporting more than 10,000 regulated products worldwide. He has led teams of 150+ quality and regulatory professionals, partnered with health authorities, supported inspections and strategic submissions, and helped organizations translate complex regulatory requirements into practical, scalable business processes.
At Hopestone, David helps IVD and medical device companies clarify regulatory strategy, strengthen quality systems, prepare for audits and inspections, improve submission readiness, manage lifecycle and post-market activities, and make better risk-based decisions grounded in real industry experience. His approach is practical, collaborative, and focused on turning regulatory and quality expectations into clear execution.
About Hopestone
Hopestone Capital and Consulting, LLC provides senior-level Regulatory Affairs and Quality Assurance consulting for IVD and medical device companies. We support organizations facing complex regulatory, quality system, audit, and product lifecycle challenges.
Our approach is practical, risk-based, and grounded in real industry experience. We help companies move from uncertainty to clarity by translating regulatory and quality requirements into actionable plans, usable processes, and sustainable execution.
Our Mission
Our mission is to help regulated medical technology companies build quality and regulatory systems that are compliant, practical, and capable of supporting safe and effective products.
We work to strengthen compliance, improve inspection readiness, clarify regulatory strategy, and help teams make sound decisions throughout the product lifecycle.
Our Vision
Our vision is to be a trusted consulting partner for companies developing, maintaining, and commercializing IVD and medical device products.
We believe quality and regulatory functions should do more than satisfy requirements. Done well, they create clarity, reduce risk, support innovation, and help organizations serve patients and customers with confidence.
READY TO DISCUSS YOUR QRA CHALLENGE?
Get Practical Regulatory and Quality Support
Whether you need regulatory strategy, audit readiness, QMS support, risk management, or interim QRA leadership, Hopestone can help you define the path forward and turn complex requirements into practical action.
Call Now
+(817) 304 2211
