Leaders in Regulatory Affairs for the Medical Device Industry

The People of PaxMed

Working with the PaxMed team means you’re working with experts in regulatory affairs, quality assurance, clinical trials, biocompatibility, biomaterials, and implantable devices. Based on your needs, a team will be tailored to ensure that your specific project is successful.

 

Floyd G. Larson, M.S., M.B.A. – President
Floyd LarsonFloyd oversees all projects and acts as a key liaison between our clients and regulatory agencies. Floyd’s educational background in chemistry, materials science, and business management prepared him for a career in science-based regulatory affairs. Before founding PaxMed, he was Vice President, Scientific Affairs for a major implantable medical device company. Floyd currently serves as Membership Secretary of ASTM International Committee F04 on Medical Devices and is Chairman of ISO/TC 106 Subcommittee 8 on Dental Implants, as well as head of the U.S. delegation to the Subcommittee. He also serves as Convener of the ISO working group responsible for standards for mechanical characterization of dental implants. He has served as the Industry Representative to the Dental Products Panel of the FDA Medical Devices Advisory Committee, and has authored and coauthored industry-related articles. Floyd was named one of MD&DI’s 100 Notable People in the medical device industry in 2008, and has been a member of MD&DI’s Editorial Advisory Board since 1993.

Kevin ThomasKevin A. Thomas, Ph.D. – Vice President and Director of Regulatory Affairs
Kevin is responsible for providing oversight for all regulatory projects, including strategy, personnel, budgets, and timelines. He is actively involved in preparation of regulatory submissions, including 510(k) Premarket Notifications, Investigational Device Exemption (IDE) applications and Technical Files submitted to Notified Bodies for review as a part of the CE Marking process. His experience includes implementation of the design control and design history file requirements of FDA 21 CRF 820. Before joining PaxMed Kevin had seven years of experience with a manufacturer of bioresorbable medical devices, with responsibilities including R&D and product development. Formerly he was Associate Professor, Department of Orthopaedic Surgery, Louisiana State University Medical Center, and adjunct faculty of the Department of Biomedical Engineering, Tulane University. He has authored or co-authored over 85 scientific journal articles and over 200 scientific paper or poster presentations.

Linda Schultz

Linda K. Schulz, B.S.D.H ., R.D.H. – Senior Clinical/Regulatory Specialist
Linda is actively involved in preparation and management of 510(k) Premarket Notification submissions with special expertise in dental devices and clinical studies. Her responsibilities include providing FDA Registration and Listing support for our clients. As a part of our clinical studies team, she contributes to the development and coordination of IDE and Post Market studies, monitors at the study center, tailors the scope of the clinical project, and manages sponsor, investigator and data-system needs. Before joining PaxMed, Linda practiced dental hygiene in a variety of dental specialty practices with a primary focus on periodontology. She has over 14 years of hands-on clinical experience and a broad background in patient management.

Ellen EsterlingEllen R. Esterline, M.A. – Senior Quality Systems Specialist
Ellen specializes in helping medical device companies face challenging compliance issues in both US and international markets. She trains clients in initiating quality systems, design controls and other quality assurance (QA) needs. Her education and experience include serving as QA for local medical device companies of implantable devices (Class II and III), conducting internal audits, and providing supplier qualification audits. Ellen’s strengths include the ability to apply the regulatory requirements to a client’s current need and an ongoing involvement with medical device regulations such as US FDA Quality System Regulation (21 CFR 820), ISO 13485:2012 for Medical Devices Quality Management Systems, Europe’s Medical Device Directive (MDD) including Notified Bodies and obtaining the CE Mark, Health Canada Medical Device Regulations and the California Food and Drug Branch.

Christine PetersonChristine L. Peterson, B.A. – Director of Clinical Studies
Christine directs our Clinical Studies Department with overall responsibility for study management, the monitoring staff, and ensuring appropriate reporting of the study. With her training in clinical trial management and her more than 14 years of Investigational Device Exemption (IDE) and post-market clinical trial experience, she provides the in-house study leadership. This includes the initial writing of the protocol and study materials, working with the staff and the client to clarify the study goals and to meet FDA’s requirements. Christine also leads clinical study training, including the design and conduct for initial and on-going training of study center personnel and monitors, and coordinates the FDA relationships and reporting requirements.

Claudia FellClaudia H. Fell, B.S. – Office Manager
Claudia is in charge of office administration, assists with document archiving and spearheads production of all regulatory submissions. She provides oversight of the myriad day-to-day tasks, and works with accounting, data management, and the regulatory departments. She also organizes staff meetings, effectively contributing to the efficiency of our team. Her experience in medical offices and hospitals, combined with her degree in mathematics and medical technology have equipped Claudia for her role in coordinating our regulatory affairs office.

Carolyn Poirier, B.A. – Manager of Business Administrationcarolyn-poirier
Carolyn is responsible for managing a variety of financial and business related projects required for our growing firm. She provides support for PaxMed’s leadership team and client relationships, with a focus on accounting and marketing. With a strong background in finance, marketing and communications, Carolyn designs strategic marketing plans, coordinates business events, updates documentation systems and assists with drafting long-term business goals. Her experience as a business owner and as a part of management teams, and her problem-solving skills contribute to PaxMed’s active role in the medical device regulatory field.