Principal Consultant Regulatory Affairs
Qserve Group US. Inc
Lorry Weaver Huffman, MT(ASCP), CLS(NCA)
Qserve Group US, Inc.
Lorry is part of the US Regulatory Affairs team at Qserve providing strategic perspectives from a manufacturer’s point of view having served on Executive Leadership teams at past companies. Areas of expertise include global regulatory strategy, regulatory planning, product development life-cycle regulatory applications, and team management. This spans novel and traditional medical devices and in vitro diagnostics across a wide product portfolio. Her main activities at Qserve are global Regulatory strategy and planning, US FDA submissions (pre-submissions, IDE, 510(k), PMA), and CE-Mark Technical File preparation and MDR /IVDR training .
Lorry has been in the medical industry for over 30 years, working in large multi-national corporations, mid-sized companies, and clinical laboratories. Some product areas include cardiovascular devices and implants, renal devices, ultrasound, and in vitro diagnostics. Lorry's knowledge spans an international level, having had global responsibilities in US, Europe, and Japan. She earned her BS in Microbiology with a minor in Chemistry from Northern Arizona University, and an MBA California State University-Sacramento. Additionally, she is a licensed Medical Technologist and Clinical Laboratory Scientist with ASCP, NCA, and the State of California.
Saturday, September 21
9:00 AM – 5:00 PM