Steve Krueger – Owner & Principal Consultant, MAK and Associates, LLC
Steve Krueger is the owner and principal consultant of MAK and Associates, based in Milwaukee, Wisconsin. With over 30 years of experience in the medical device industry, he is a recognized expert in verification, validation, and post-market surveillance.
Formally trained as a computer engineer, Six Sigma Black Belt, and technical manager, Steve has held diverse roles spanning software engineering, systems integration, quality engineering, verification and validation leadership, service engineering, and quality/regulatory leadership. His experience ranges from working with small startups to Fortune 100 companies, giving him a unique perspective on the challenges and opportunities across the industry.
Steve has successfully led numerous product testing efforts, leveraging practical planning, risk-based management, and strategic execution to ensure regulatory compliance and product safety. A dedicated educator and mentor, he has taught risk-based verification and shares his hands-on, common-sense approach with customers and industry peers.
With a passion for advancing medical device innovation, Steve is committed to helping companies navigate the complexities of product development and market entry with confidence and efficiency.
Personal Connection
My journey into medical device consulting is deeply personal. As a parent of six children with Type 1 diabetes, I’ve experienced firsthand the critical role that innovative medical devices play in managing chronic conditions. From insulin pumps to continuous glucose monitors, I’ve navigated the evolving landscape of diabetes technology not just as a consultant, but as a caregiver and advocate.
This personal connection fuels my passion for guiding medical device startups through the complexities of regulatory approval, quality assurance, and market entry. I understand the urgency of bringing safe, effective, and life-changing devices to patients who depend on them every day. With a deep appreciation for both the technical and human aspects of medical innovation, I help companies streamline development, avoid regulatory pitfalls, and bring their solutions to market faster—so that families like mine can benefit from the next breakthrough in healthcare.