Shannon Hoste, former lead for FDA Human Factors Team, is named President of Agilis Consulting Group
CAVE CREEK, Ariz., Oct. 5, 2021 /PRNewswire/ -- Agilis Consulting Group, a full-service medical human factors firm that helps new and established companies achieve successful human factors submissions, has named Shannon Hoste as President.
"We are excited for this next stage of growth," said Pat Patterson, CEO of Agilis Consulting Group. "Agilis has played a key role in the growth of human factors in the life sciences industry over the last 20 years. Shannon's vision will allow Agilis to continue that growth and leadership. We're thrilled to have her accept the role of President, I know we will continue to lead and serve our clients with integrity."
Shannon brings over 20 years in the medical device, pharmaceutical and in vitro diagnostic industries. Together with her FDA regulatory experience in both CDRH and CDER, where she provided oversight to hundreds of human factors submissions, she is a recognized expert in risk management and product development. As a leader, Shannon has previously architected product development, human factors, and risk management processes within medical device companies from start-up to Fortune 100. As an engineer, she has developed, launched, and sustained combination products, medical devices and IVDs.
Today Shannon is the President of Agilis Consulting Group, an assistant professor in the Quality Science Education program at Pathway for Patient Health and is active on several standards and conference committees for medical devices and combination products.
"It was an honor to join Agilis and Pat Patterson's team last year. I am ready to begin this new role with a clear vision to grow the Agilis service offerings through strategic partnerships and product solutions. Our team is also actively monitoring the evolving regulatory landscape and continuing to build our expertise into growing industries such as cybersecurity and digital health including software as a medical device and AI/machine learning," Shannon stated.
About Agilis Consulting Group
Agilis Consulting Group is your trusted human factors partner for the global medical market. We enable product realization through successful human factors submissions while navigating the complex global regulatory landscape, resulting in safe and effective medical devices and combination products. Agilis' proven human factors strategies, process and expertise drive regulatory success and speed to market – the first time.
To learn how Agilis can support your medical device or combination product human factors success, please contact [email protected] or visit us at www.agilisconsulting.com
SOURCE Agilis Consulting Group
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