I am currently working as an independent contractor available for consulting assistance with FDA processes. I am an accomplished biomedical engineer with extensive knowledge of FDA regulations. I have worked with a regulatory group attempting to launch innovative vascular interventional products in the US Market. Previously, I worked in the Office of Device Evaluation at the FDA and examined pre-market submissions for cardiac medical devices, specifically devices that are inserted into the coronary arteries and the devices used in the interventional procedure. Drug eluting stents, atherectomy systems, percutaneous transluminal coronary angioplasty balloons, guide catheters, and embolectomy catheters are just a few of the devices that I am responsible for reviewing. Previously, I reviewed dental devices such as implants, abutments, bone-grafting materials, bone plates, and trans-mandibular joint implants.
Specialties: Cardiovascular devices, FDA regulations, project management, biomedical engineering, thermodynamics, vascular intervention