This SPARK Studio session will provide a high-level overview of the U.S. FDA regulatory framework for medical devices, focusing on key requirements for manufacturers. Topics will cover FDA classification system (Class I, II and III), product code selection and premarket pathways (i.e. 510(k), PMA, De Novo). Attendees will gain insights into the submission process, predicate device selection, and ongoing compliance obligations under FDA guidelines.
Alexandra (Alex) Schardt, Manager, Regulatory Affairs for MCRA will be hosting this talk. Alex has over 7 years of experience in the biotechnology industry and medical device regulatory affairs. Alex is RAC-certified in medical device regulatory affairs.
As Manager, Regulatory Affairs, she specialises in both US FDA and international regulatory strategy, writing regulatory submissions, development and maintenance of technical and regulatory documentation, conducting systemic literature reviews, and performing gap analyses. She leads and supports regulatory projects from regulatory strategy assessments through final submission writing and communications with the FDA and Notified Bodies. Alex has supported projects including Clinical Evaluation Reports (CERs), Technical Documentations, 510(k)s, Pre-Submissions, De Novo 510(k)s, Investigational Device Exemptions (IDE), and Premarket Approval (PMAs). She has supported regulatory projects in the orthopaedic, spine, neurology, and cardiovascular spaces.
Before joining MCRA in 2021, Alexandra worked in viral vector product development at a privately hed biotech company. Alexdra received her Bachelor of Science for Gettysburg College in Biochemistry and Molecular Biology. Alexandra also received a Master of Science in Biotechnology from Johns Hopkins University, concentrated in Regulatory Affairs.
This SPARK The Midlands event is being delivered as part of Aston University's active involvement in the delivery of the West Midlands Health Tech Innovation Accelerator (WMHTIA). The WMHTIA is funded by the Department for Science, Innovation and Technology, in partnership with Innovate UK and the West Midlands Combined Authority.
