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 CEO
An advantage maker to the medical device industry, Mr. Morgan is best known for his work in electrochemistry; 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 med-device community. Mr. Morgan possesses expert know-how in regulatory submission drafting, platform strategy, intellectual property, and project management.
Mr. Morgan is currently expanding Eagle's growth strategy; requiring new business methods for improving volume, speed-to-market and customer service. These are adjunct areas to 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, Mr. Morgan gained a BSc. in Mechanical Engineering and a 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 Mr. Morgan was also awarded Project Management Professional designation from the Project Management Institute. At Eagle Medical, he leads with efficient and FDA compliant manufacturing, sterilization, packaging & packaging design service options for the medical device industry.
Mr. Chris Hunting joined the Eagle Medical team in 2019. With his vast experience in the financial arena, his skills are a great attribute in managing the company’s accounting and finance department.
Chris has been in the accounting & finance industry for over 16 years. He received his Bachelor’s degree in Business Administration with an emphasis in accounting and finance from Columbia College. In 2011, Chris became a Certified Public Accountant (CPA) and keeps his license current to stay on top of the ever-evolving accounting laws.
As a former business owner of his own accounting practice, Chris has an entrepreneurial perspective that gives him a big picture view of what is necessary to keep a company healthy and growing. Mr. Hunting provides Eagle with the accurate knowledge of finance to maintain a financially strong business while simultaneously navigating the expansions needed to meet our growing customer demands.
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. Ms. Jody Birks’ breadth of experience and technical industry knowledge enables her to consistently drive quality assurance and regulatory success.
Ms. Birks 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. Ms. Birks 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, Ms. Birks 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.
Sr. Quality Engineer
Wes McDonald is a military veteran with over 20-years experience as a packaging engineer in the medical device industry. Leveraging this experience for Eagle Medical Packaging, Sterilization Inc. and leading the Quality Department
into the future of packaging and sterilization is Mr. McDonald’s main priority. He started studying systems engineering at the United States Military Academy at West Point, NY. After his military service, Mr. McDonald started in the medical
device industry as a quality engineer, and quickly specialized in packaging engineering while studying packaging at San Jose State University.
Throughout his career, he has been instrumental in packaging design, process qualification, and quality systems; assessing the entirety of the manufacturing and distribution environments to optimize the packaging experience for all involved in it. Mr. McDonald is driving the world-class quality that is the benchmark at Eagle for your packaging and sterilization needs.