Founder & Principal Consultant
Bensolutions, LLC
Engineering excellence across regulated industries. Specialized in AI integration, medical device software, and technical leadership with proven regulatory compliance expertise.
Bridging the gap between cutting-edge innovation and regulatory compliance
At Bensolutions, we bridge the gap between cutting-edge innovation and regulatory compliance. Our mission is to provide B2B clients with premium technical expertise that combines modern AI/ML technologies with deep regulatory knowledge gained through decades of experience in regulated industries.
We specialize in helping CTOs, engineering managers, and healthcare executives navigate complex technical challenges while ensuring compliance with FDA, ISO, and other regulatory standards. Our personalized approach means you get direct access to proven expertise, not a team of junior consultants.
Work directly with Carl Michael Benson, not a team of junior developers. Get 25+ years of experience focused on your project.
Deep knowledge of FDA, ISO, HIPAA, and GDPR requirements. Proven track record with 3 medical devices brought to market.
Unique combination of healthcare, industrial automation, aerospace, and AI expertise. Patent holder with published research.
Comprehensive evaluation of your technical challenges, regulatory requirements, and strategic goals.
Hands-on implementation with proven methodologies, ensuring compliance and technical excellence throughout.
Ongoing technical leadership and knowledge transfer to ensure long-term success and team empowerment.
25+ years of engineering excellence across regulated industries
Started in industrial automation and SCADA/HMI systems, building expertise in real-time control systems and embedded programming that would prove invaluable in later medical device development.
Nine transformative years developing medical device software and leading teams that brought 3 successful medical devices to market. Co-invented 2 patents for medical device fluid delivery systems while mastering FDA compliance and regulatory validation processes.
Transitioned into AI/ML implementation and technical leadership, combining regulatory expertise with cutting-edge technology. Founded Bensolutions to provide specialized consulting that bridges traditional engineering with modern AI capabilities.
Innovation backed by intellectual property. Co-inventor of 2 medical device patents with verifiable links to official patent databases worldwide.
Advanced medical device control systems for precise fluid delivery in clinical environments. Focuses on safety-critical software and regulatory compliance for healthcare applications.
Innovative injection systems designed for precise contrast media delivery in medical imaging. Features advanced control algorithms and safety mechanisms for clinical environments.
These patents represent breakthrough innovations in medical device technology, contributing to safer and more precise healthcare delivery systems. Each patent reflects deep expertise in FDA-compliant software development and safety-critical systems design.
Unique expertise that bridges traditional engineering excellence with cutting-edge innovation, backed by a proven track record in regulated industries.
Deep expertise in FDA 21 CFR Part 11, ISO 13485, IEC 62304, HIPAA, and GDPR compliance. Proven track record of bringing medical devices through regulatory validation processes.
Unique perspective gained from 25+ years across multiple industries, enabling innovative solutions that leverage best practices from healthcare, industrial automation, aerospace, and financial services.
Co-inventor of 2 medical device patents with published SPIE research. Intellectual property backed expertise demonstrating innovation capability and deep technical understanding.
Where most consultants offer either modern AI expertise OR regulatory compliance knowledge, Bensolutions uniquely combines both with 25+ years of proven results. This rare combination enables innovative solutions that meet today's technology demands while ensuring regulatory compliance.
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