Eagle Medical Inc. offers efficient and FDA compliant assembly, packaging and in-house Hydrogen Peroxide Gas Plasma (HPGP) specific, as well as contract irradiation (gamma and e-beam) sterilization services for the medical device industry. Validation services for manufacturing processes, packaging, and sterilization are customized to product specific requirements. The company is dedicated to industrial sterilization requirements and meeting the highest of industry standards: FDA registered, ISO 13485:2016 Certified, audited in accordance with ISO 14937:2009 and compliant with ISO 14644-1 CLASS 7 (Class 10,000) Cleanrooms.
President and Chief Executive Officer
An advantage maker to the medical device industry, Roy Morgan, CEO, is best known for his work in electrochemistry; the inventor of the world's first orthopedic device to upregulate genetic progenitor compounds in the healing process of osteoarthritis of the joints. His skills in R&D team building and fast-paced project execution, requiring FDA product acceptance are well known in the medical device community. Roy is an expert in regulatory submission drafting, platform strategy, intellectual property, and project management.
Roy is expanding Eagle's growth strategy; requiring new business methods for improving volume, speed-to-market, and customer service. These are adjunct areas in which Mr. Morgan has consistently excelled having launched many medical devices with companies such as Abbott Laboratories, Meditrina, and Stryker. Using his "advantage maker" leadership approach, he has brought to market episodic blood glucose meters; wireless continuous glucose monitoring systems; drug infusion pumps; and several electrosurgical systems.
His product design skills are highly sought after as are his engineering skills in both electromechanical engineering and injection molding. Educated at Brown University, Providence, Rhode Island, Roy earned his BSc. in Mechanical Engineering and his BA in Semiotics. At the University of California at Berkeley he became a Registered Professional Engineer and was awarded a Certificate in Project Management. In 2000, he was also awarded Project Management Professional Designation from the Project Management Institute. At Eagle Medical, Roy leads with efficient and FDA-compliant manufacturing, sterilization, packaging & packaging design service options for the medical device industry.
Chief Financial Officer
Chris Hunting has been serving as Eagle Medical's CFO since 2019. He brings a wealth of financial expertise to the team having been in the accounting and finance industry since 2005. Chris earned a Bachelor's degree in Business Administration with a focus on accounting and finance from Columbia College. His professional journey includes obtaining a Certified Public Accountant (CPA) license in 2011, working with a public accounting firm, and eventually establishing his own accounting business, offering accounting and consulting services.
Chris's entrepreneurial background affords him a comprehensive understanding of the multifaceted requirements of a thriving company. His strategic insight and financial astuteness create a solid foundation for Eagle Medical's continued growth and success. Skillfully managing the company's accounting and finance department, Chris ensures financial stability while proactively navigating the evolving business landscape and meeting the ever-growing demands of our valued customers.
Regulatory Affairs & New Product Introduction
With over two decades of medical device contract manufacturing and sterilization experience, Jody Birks has distinguished herself in the industry with efficient and FDA compliant solutions to complex packaging and sterilization challenges.Jody's breadth of experience and technical industry knowledge enables her to consistently drive quality assurance and regulatory success.
Jody ensures that Eagle Medical’s quality management system is fully compliant with FDA QSR and ISO 13485:2016. Her understanding of validation requirements for manufacturing, packaging, and sterilization processes is extensive. Manufacturing processes performed by Eagle Medical are validated per customer-specific protocol. She has performed a variety of packaging validation studies following ISO 11607. She has also conducted a variety of sterilization validations: irradiation (gamma and e-beam), following ISO 11137 and Hydrogen Peroxide Gas Plasma (HPGP) in compliance with ISO 14937 guidelines. Jody provides all documentation support for the OEM
regulatory submissions and manages the entire process of onboarding contract packaging and sterilization services with full compliance to Quality System Requirements.
In addition, Jody is serving on multiple AAMI Sterilization Committee working groups developing sterilization standards. She has technical writing experience that complements all document control functions. Her academic background includes a Bachelor of Science in Environmental and Systematic Biology with a minor in Communication at California Polytechnic State University, San Luis Obispo.
Production Manager