Demystify the Regulatory Environment: A Roadmap for Healthcare Technologies
Healthcare regulations can be daunting, get expert advice to successfully navigate through the FDA and regulatory compliance.
Join Brie Stoianoff to hear the most critical aspects of healthcare regulations for medical devices, diagnostics and therapeutics. Knowing the federal regulations applicable to your technology can help you successfully advance your technology to improve patient care, determine health insurance coverage, and help you gain access to both domestic and global markets. Seeking regulatory information early will help you avoid common pitfalls during technology development that could stall your innovation.
Brie has spent more than twenty years helping entrepreneurs and companies realize their quality and regulatory goals. Product types she has worked on have varied from orthopedic implants, bedside and high acuity vital signs monitoring systems, AEDs, lateral flow IVDs and integrated operating room display systems as well as parenteral and solid oral pharmaceuticals. In addition to providing consulting services to small and midsized companies, Brie has worked for many large companies including AstraZeneca, Welch Allyn (now Hill-Rom) and Shire. She currently works as the Regional Director for Healthcare Alliances at Philips, supporting OHSU, Legacy and PeaceHealth. She has a Bachelor’s in Chemistry and History from The College of Idaho and a Master’s in Quality Assurance and Regulatory Affairs from Temple University School of Pharmacy and is pursuing a Master’s of Public Health at OHSU/PSU.