Stacy Suhay
Director of Business Development @JALEX Medical, LLC
Signup · Get unlimited contacts
WORK HISTORY
Director of Business Development @JALEX Medical, LLC
Medical Device Design, Product Development & Regulatory Consulting: Accelerating Concept to Market Medical Device Design & Development - Concept Generation and 2D/3D CAD - Medical Device Design per FDA regulations - Finite Element Analysis - Find manufacturing resources to create prototypes and production parts Quality - Quality Management System Development and Implementation per 21 CFR 820 - ISO 13485, FDA, MDR, and Canadian Directive General and Facility Specific Training Programs - Company Representative during external audits by Regulatory and Third-Party Auditors - FDA remediation assistance for 483 observations and warning letters Regulatory - Regulatory Path Assistance & Product Classifications (Class I, II, 510(k) submissions - Predicate Device Research - Device/Instrument Registration & Listing
EDUCATION
Kent State University
Bachelors of Science, Health Science, Gerontology, Psychology
ABOUT STACY SUHAY
With over 13 years of experience in the medical device industry, I am passionate about…
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.