We're delighted to announce today that Monroe Medical Devices has come onboard as our first US Qualio (formerly ZenDoc) partner. We are looking forward to working with James and his clients in the future.
Here is a copy of the press release:
Somerset, NJ -- 09/16/2013 -- August 2013, MMDC provides Regulatory and Quality Assurance expertise, specializing in FDA Class I & II (US) regulatory submissions and compliance. MMDC’s quality objective is to help companies meet the FDA’s QSR and ISO 13485 requirements though the audit process. Additionally, MMDC provides consulting services for developing short and long-term regulatory strategies for new product development, 3rd Party Inspections, and remediation.
Partnering with Qualio will provide a unique opportunity to make sure that small to medium sized companies can bring medical devices to the market place and be in compliance with 21 CFR Part 11 and quality management systems compliance rules.
“We’re excited to partner with Qualio to co-market and provide an affordable quality management system, in addition to providing expert regulatory and consulting services through the software”, says James W. Monroe, CEO MMDC.
We view this partnership as beneficial to both companies and clients. This solution can help companies bring medical devices to the market in an affordable manner while adhering to GMP, QSR, and ISO 13485 compliance.
Qualio was founded in 2012 to develop a quality management platform that simplifies compliance for businesses in the Life and Health sciences industry. The inspiration for Qualio came from a combination of Robert’s background in the Pharmaceutical industry and his experience with
EasySOP, a company that creates quality systems for healthcare businesses.
Based in the heart of Dublin city, the company works closely with customers and partners to craft the best solutions for reducing the burden of managing quality & compliance.
About Monroe Medical Device Consulting™ LLCM
MDC was founded in June of 2013 under the premises of organizing a strong management group that would: 1) work leverage existing technological skills to establish a foot hold in the global medical device market through partnerships and collaborations. 2) grow the company by expanding and diversifying our medical device technological capabilities through certifications, professional societies and industry intelligence.
Monroe Medical Device Consulting™ LLC. Our goal is to provide expert class service and reduce the time to market of your medical device.