ClearPath Device Strategies, Inc.
Navigate Complex Regulatory Pathways with Clarity and Confidence
What We Do
ClearPath Device Strategies was founded to help medical device and life-sciences companies move complex products and programs forward with greater clarity, efficiency, and confidence. Led by Corey Josenhans, a medical device executive with more than 25 years of experience across research and development, quality systems, manufacturing, regulatory support, and product commercialization, we combine strategic leadership with hands-on execution to deliver practical solutions.
Our expertise spans Class II and Class III medical devices, combination products, implantable devices, electromechanical systems, and other regulated healthcare technologies. We’ve successfully guided companies from early development through verification, validation, regulatory submission, manufacturing transfer, and commercial launch—helping clients identify practical solutions, manage risk, strengthen compliance, and bring safe and effective products to market.
Our Services
Product Development & Regulatory Strategy
Comprehensive support for medical device product development, design controls, Design History File preparation, risk management, and regulatory submission strategy. We guide you through the entire development lifecycle with technical documentation and compliance expertise.
Quality Systems & Manufacturing Excellence
Establish and optimize quality management systems, verification and validation planning, manufacturing transfer, and process validation. Our services ensure your products meet regulatory requirements and maintain the highest quality standards from development through commercial production.
Human Factors & Program Leadership
Expert guidance in human factors and usability engineering, product development and remediation program leadership, and cross-functional project and portfolio management. We help you navigate complex programs and deliver user-centered solutions that meet market needs.