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Kevin Walls
US Agent, FDA 510(k), PMA, Canada Medical Device License, CE Mark, Clinical Study, Quality System Regulation, ISO 13485
Professional Background
Kevin Walls is a highly respected medical device regulatory consultant with extensive experience in navigating the complex landscape of FDA regulations and international medical device compliance. With over a decade in the industry, Kevin has established himself as a reliable authority in areas including FDA 510(k) submissions, premarket approvals (PMA), and the medical device licensing processes in jurisdictions such as Health Canada and Europe (CE mark). His expertise not only encompasses regulatory submissions but also includes human clinical studies and the establishment of comprehensive quality systems to ensure compliance with FDA Quality System Regulation and ISO 13485 standards.
Kevin is the principal consultant at Regulatory Insight, Inc., where he leads a team dedicated to providing critical regulatory support to medical device manufacturers, foreign exporters, importers, repackagers, relabelers, and contract manufacturers. His firm specializes in facilitating the often daunting regulatory pathways required to bring innovative medical devices to market. Notably, Kevin serves as the US Agent for FDA matters for over 100 companies globally, underscoring his vital role in ensuring that manufacturers meet the stringent regulatory standards necessary for product approvals.
Education and Achievements
Kevin holds a Master of Business Administration (MBA) with a focus on Operations Management from Regis University. This educational foundation has equipped him with a strong understanding of the operational aspects of regulatory compliance, further enhancing his ability to assist clients in navigating the complexities of medical device regulations efficiently.
Throughout his career, Kevin has held significant positions in various prestigious organizations, including:
- Principal Consultant at Regulatory Insight, Inc. – Leading a team that specializes in regulatory consulting for medical device manufacturers.
- Consultant at Cerapedics – Provided expert guidance on regulatory matters pertaining to medical devices.
- Consultant at EraGen Biosciences – Assisted in regulatory affairs related to biosciences and their medical applications.
- Consultant at Dentsply Friadent Ceramed – Contributed to regulatory strategies in the dental device sector.
- Associate Consultant at Quintiles Consulting – Worked on a variety of projects that required a solid grasp of regulatory compliance in clinical settings.
- Director of QA/RA at Fischer Imaging – Oversaw quality assurance and regulatory compliance initiatives.
- Senior Regulatory Affairs and Quality Systems Development Specialist at GAMBRO Healthcare – Specialized in quality system regulations and regulatory affairs.
- Technical Services Manager at Cochlear Corporation – Managed technical services related to cochlear implants and their regulatory requirements.
- Production Test Manager/Electrical Design Engineer at Bard Electro Medical Systems – Involved in the engineering and testing of medical electrical devices.
These roles have not only expanded Kevin's expertise in regulatory affairs but have also provided him with a unique perspective on the medical device industry from various angles, enhancing his capabilities as a regulatory consultant.
Achievements
Kevin's career is characterized by numerous achievements that demonstrate his commitment to excellence in regulatory consulting. He has established a strong network within the medical device industry, which allows him to stay updated on the latest regulations and best practices.
Some notable achievements include:
- Successfully guiding over 100 global companies through FDA submissions and approvals, enabling them to bring their innovative medical devices to the U.S. market.
- Developing and implementing quality management systems compliant with FDA Quality System Regulation (QSR) and ISO 13485 for several clients, resulting in increased operational efficiencies and enhanced product quality.
- Leading teams in clinical study designs that have been instrumental in securing regulatory approvals for ground-breaking medical technologies.
- Providing training and consultancy services that have empowered clients to independently manage their regulatory affairs over time.
In conclusion, Kevin Walls is a distinguished medical device regulatory consultant with a wealth of experience and proven success in the regulatory domain. His educational background combined with years of hands-on experience in various aspects of medical device regulation makes him an invaluable asset to organizations looking to navigate the intricate regulatory landscape. Kevin's passion for aiding medical manufacturers and his strategic insight into operations management help facilitate the essential pathway for medical devices to reach patients safely and effectively.
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