John Marszalek

John Marszalek

Consultant

Mr. Marszalek joined Biologics Consulting in 2020 with 18 years of experience as a biomedical and electrical engineer. Mr. Marszalek spent the past 9 years as a lead reviewer in the Office of Device Evaluation (ODE), Division of Neurologic and Physical Medicine (DNPMD) and Division of Anesthesia Respiratory General Hospital Infection Control and Dental (DAGRID), where he evaluated a wide variety of device and submission types. Several examples of his device expertise include power/ mechanical/ standup & stair-climbing wheelchairs, powered muscle stimulators, transcutaneous electrical nerve stimulators (TENS), electrosurgery devices, powered lower extremity exoskeleton, ventilators, etc.…

Mr. Marszalek also served as a consumer safety officer in the Office of Compliance (OC), Division of International Compliance Operations for all device types manufactured in foreign countries.

Prior to joining FDA, Mr. Marszalek spent 4 years as an equipment loss consultant at LWG Consulting analyzing cause and extent of damage to electrical and mechanical equipment for the insurance industry. Prior to that, Mr. Marszalek worked as an engineer for a cylinder manufacturing company, process engineer at a hearing aid company and validation engineer at a major pharmaceutical manufacturer and packager.

As a consultant for Medical Devices with Biologics Consulting, Mr. Marszalek utilizes his scientific and regulatory expertise to assist clients in the following areas:
• Preparation of device submissions (Q-Sub, 510k, PMA, IDE, etc.)
• Short- and long-term regulatory strategy for medical devices
• Product development and preclinical testing strategies
• Crafting responses to FDA deficiencies and communicating with FDA on behalf of clients


Education

John received his BS in Biomedical Engineering in 2000 from Arizona State University and MS in Electrical and Computer Engineering from Northwestern University in 2004.