Laura comes to the lean RAQA team with a Master’s in Biomedical Engineering and more than six years of regulatory experience in the medical device and pharmaceutical industries.
She has brought multiple medical device products to market through the FDA’s 510(k) submission process which relies on demonstrating substantial equivalence to another device. She has supported multiple medical devices in the EU including under MDR. She is a labeling maestro and has extensive Quality Management System experience with new startups, established large companies, and in between.
Laura also has expertise in FDA submissions of generic drug products, or abbreviated new drug applications (ANDAs). These submissions require no pre-clinical or clinical data to demonstrate safety and effectiveness, but must still show that the product performs the same way as the innovator drug.
Fun Fact: Laura has led a somewhat nomadic life and has lived in seven states and 2 countries.