SPARK Studio workshop | The FDA Pathway - How Medical Devices Get to Market | SPARK The Midlands | Alexandra Schardt

Led by industry experts, SPARK The Midlands has organized a series of lectures and workshops called SPARK Studio to promote innovation in healthcare technology in the region.

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.