RegulatoryQualityCompliance

Navigation and Streamlining the Global Regulatory Arena!

(908) 809-0081


Available as needed after regular office hours | Hours of Operation: Monday – Friday: 8:00 AM – 6:00 PM

Our Areas of Expertise

c

Radiology

MRI, CT, Ultrasound, PET, Nuclear Medicine, X-Ray, PACS

Cardiology

Cardiovascular Imaging, Cardiac Heart Monitor, Angiography, EKG Devices

_

AI

Artificial Intelligence/Machine Learning

Infusion Pumps

Infusion Pumps

App

Mobile Medical App
l

Software, as Medical Device

Software, as Medical Device

Fiberoptics

Lasers & Fiberoptics

Electro-Mechanical Software

All Electro-Mechanical Software Driven Devices
P

Cybersecurity

Cybersecurity
Z

Implants

Implants
b

Endoscopic Devices

Endoscopic Devices

Diagnostics

In-Vitro Diagnostics

About Our CEO

Over the past 20 years, James has been exclusively involved in the medical device field, focusing on Regulatory Affairs and Quality Assurance. Within this arena, he has focused on getting medical devices registered globally. His background and track record demonstrates his leadership, from product concept through obsolescence, by (1.) ensuring regulatory compliance, (2.) providing strategic, tactical and operational direction and support for working within the regulations to expedite the development of safe and effective products, (3.) preparing/submitting submissions and managing communications with the Regulatory Bodies, and (4.) keeping up-to-date with changes to the regulatory environment, science and technology, the medical device industry and the healthcare sector through regulatory intelligence.
His regulatory focus is to develop and execute regulatory strategies for clients domestically and internationally. He has successful gain multiple 510(k) clearances in the US, and approvals in the EU, Canada, South Korea, and Japan. He is at the forefront of regulatory intelligence, staying abreast of the ever-changing medical device requirements globally.

He also holds both a Bachelor’s and a Master’s of Electrical Engineering. His Post-Graduate studies were conducted in the Department of Radiology at The Ohio State University, where he 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.

He has held several leadership positions within regulatory and quality, including Director of Regulatory and Clinical at Pharmatech Associates-Medical Devices, Director Regulatory, Pentax Medical, Director of Regulatory & Quality at Immacor Inc., Interim Director at Convatec Inc., Manager of Regulatory at B. Braun Medical. In his role as a consultant, he has worked globally with clients as the key regulatory expert responsible for developing regulatory strategies and gaining approval/clearance in multiple countries. He has also served as a 3rd party reviewer for the FDA’s 510(k) program at Intertek.

market in a more streamlined manner. In 2020, based on the ever-evolving and changing global regulatory requirements, he launched a new medical device company, Global RQC Med Device Solutions, whose goal is to provide a global level of expertise to companies seeking global assistance with device registration and regulatory compliance. He is currently pursuing an MBA at Rutgers University’s School of Business, focusing on Leadership and Finance.
His device specialties include but are not limited to Electro-mechanical and software-driven devices, in-vitro diagnostics, digital health (Software as Medical Device, Artificial Intelligence, Machine Learning, Cybersecurity), and Risk Management.

 

Learn more about our president and CEO, James Monroe.

His regulatory focus is to develop and execute regulatory strategies for clients domestically and internationally. He has successful gain multiple 510(k) clearances in the US, and approvals in the EU, Canada, South Korea, and Japan. He is at the forefront of regulatory intelligence, staying abreast of the ever-changing medical device requirements globally.
Learn more about our president and CEO, James Monroe.