JAMES MONROE

Mr. Monroe has been working exclusively in the medical device field focusing on Regulatory Affairs and Quality Assurance for the past 20 years. He has a proven track record with global medical device registrations. Provided medical device leadership from product concept through approval ensuring regulatory compliance and strategic tactical and operational direction and support.

He also holds both Bachelor’s and Masters degrees in Electrical Engineering. His Post-Graduate studies were conducted in the Department of Radiology at Ohio State University where Mr. Monroe developed hardware and software applications for the MRI systems and accessories. He has published multiple peer reviewed papers on image processing of medical images for image improvement.

Mr. Monroe has held several leadership positions within small to mid-size regulatory and quality organizations. In his role as consultant he has worked globally with clients as the key regulatory expert responsible for developing regulatory strategies and gaining approval and clearance in multiple countries. He has also served as a 3rd party reviewer for the FDA’s 510(k) program at Intertek. With the establishment of his own company in 2013, Monroe Medical Device Consulting LLC, he was able to further reach a broad range of clients and bring products to market in a more streamlined manor. Currently, he is an Adjunct Professor of RA/QA in the School of Pharmacy at Temple University.

One of Mr Monroe’s specialties is in the area of Electro-mechanical and software driven devices. He has received clearance of over 35 510(k)’s, of which 90%, involved software. Most recently he has focused his regulatory experience in the area of digital health that includes: Software as Medical Device, Artificial Intelligence, Machine Learning, Cybersecurity, and Risk Management.

His regulatory focus is to develop and execute regulatory strategies for clients both domestically and internationally. Mr. Monroe has successfully gained multiple 510(k) clearances in the US, and approvals in the EU, Canada, South Korea, and Japan.