Founder, President & CEO

As the unequivocal leader of Qualira, Scott aspires to provide the best services to his clients as well as rewarding opportunities for his staff. Prior to starting A Wright Path Inc., he spent over 20 years in various regulatory affairs and quality assurance roles in regulated industry and is a previous Notified Body (BSI) Assessor. With an outright mastery of how to navigate the regulatory environment, he brings an immense amount of knowledge and leadership to our team of seasoned industry professionals.

Project SME – Technical Services

With over 30 years of experience in Quality Assurance and Regulatory Compliance, Sharon specializes in Medical Device Microbiology. Sharon serves as Qualira’s subject matter expert for sterilization, biocompatibility, cleaning and reuse issues, packaging/shelf life, and failure analysis. She will partner with you to draft protocols, reports, review DHRs, and perform risk analysis and provide technical expertise when compliance issues arise. Sharon holds a BS in Microbiology.

Project SME

Dr. Kristie Burgess is a seasoned bioengineer and clinical affairs expert with 18 years of experience across startups and global medical device leaders, specializing in Class II and III products in orthopedics, cardiovascular, and pulmonary life support. She excels in clinical trial strategy, design, and execution, managing all phases from protocol development to data analysis and regulatory submissions, including 510(k)s, IDEs, PMAs, and EU MDR documentation. With a Ph.D. in Bioengineering and hands-on clinical experience caring for patients with mechanical circulatory support devices, Kristie bridges the technical and clinical worlds, fostering cross-functional collaboration to advance innovative technologies that improve patient outcomes. Her results-driven approach has contributed to successful regulatory approvals, expanded product indications, and comprehensive clinical and regulatory documentation, making her a vital partner in navigating complex industry landscapes.

Project SME – Clinical Services

Christine (Chris) Hoyer is a Registered Nurse and Certified Clinical Research Associate (ACRP CCRA) with over 30 years of experience in clinical research in multiple therapeutic areas and products (medical devices, pharmaceuticals, combination products and in vitro diagnostics). Chris integrates her hands-on clinical experience with extensive research expertise to lead clinical research projects to successful outcomes. Chris is known for successfully coordinating with multi functional teams, including engineering, marketing, data management, software development and risk management to achieve regulatory approvals and plan future products. She excels in navigating complex clinical and regulatory challenges to achieve positive outcomes with regulatory agencies.

Project SME – Regulatory Services

Deval Patel is a results-driven, self-starting, and highly engaged regulatory affairs consultant with over a decade of experience in FDA and international regulatory submissions. His expertise spans a broad range of clinical areas, including pharmaceuticals, biologics, combination products, and Class I, II, and III medical devices. Deval has collaborated with more than 65 startups and major medtech corporations—including Stryker, Medtronic, and BD—providing strategic regulatory guidance to support product development and global market access. His experience covers technologies in radiology, infusion systems, Software as a Medical Device (SaMD), orthopedics, physical medicine, and digital therapeutics. Holding a Bachelor’s degree in Pharmacy and a Master’s in Regulatory Affairs, Deval is adept at developing and executing complex regulatory strategies—especially in the evolving domains of artificial intelligence and machine learning in medical software. He is known for his regulatory leadership, project management, and mentoring, and excels at working collaboratively with cross-functional teams including marketing, risk management, cybersecurity, labeling, and human factors.