Founder, President & CEO
Scott Wright
Scott brings more than 30 years in regulatory affairs and quality assurance roles in regulated industry. He is a previous BSI Notified Body assessor and leads Qualira's team of industry specialists.
THE TEAM
Senior specialists who can connect the whole program.
Qualira brings regulatory, clinical, quality, and technical services expertise together so your program does not have to be managed in fragments.
Talk with the team →
Project SME, Regulatory Affairs & Quality Management
Deval Patel
Deval has more than a decade of FDA and international submission experience across pharmaceuticals, biologics, combination products, and Class I, II, and III devices. His experience includes radiology, infusion systems, SaMD, orthopedics, physical medicine, and digital therapeutics.
Project SME, Clinical Affairs
Christine Hoyer
Christine is a Registered Nurse and Certified Clinical Research Associate with more than 30 years of clinical-research experience across devices, pharmaceuticals, combination products, and in vitro diagnostics.
Project SME, Clinical Affairs
Kristie Burgess
Dr. Burgess is a bioengineer and clinical-affairs specialist with 18 years of experience across startups and global device leaders, with particular experience in Class II and III orthopedics, cardiovascular, and pulmonary life-support products.
Project SME, Technical Services
Sharon Morford
Sharon has more than 30 years of quality assurance and regulatory compliance experience, specializing in medical-device microbiology, sterilization, biocompatibility, cleaning and reuse, packaging and shelf life, and failure analysis.