About Us
We've been supporting medical devices for over 20 years, and business formation for over 15. Now, we're leveraging that experience to help you succeed. Read our unique story below.
About QNR Compliance
The QNR Compliance Team: Quality and Regulatory Compliance is what we do.
The QNR team has over 20 years experience in the medical device industry, and has corresponded routinely with the FDA, notified bodies, agencies and other third parties for many years. QNR support businesses throughout the complete device life with a global scope, from development, commercial release, and post market activities through end of life.
QNR Compliance: Over 15 Years of Growth and Continuous Improvement
The QNR story started in 2006, when the team established its first business in the U.S. in the state of Ohio, and served as the statutory agent / registrant for that business. Over the next several years, the team has served as agent/representative for numerous businesses, including various businesses in the states of Ohio as well as businesses in the states/jurisdictions of Nevada and Puerto Rico. The QNR team has also supported filings and other day to day business for and/or with many other companies, including various large corporations based in Delaware.
Over the past 10+ years, the QNR team has placed primary focus on agency compliance for medical devices with respect to the FDA in the U.S., as well as other markets globally. The QNR team has either hosted and/or supported numerous FDA inspections, notified body audits (ISO, MDSAP, and technical documentation reviews for CE marking) and other third party reviews with successful outcomes. The team has routinely corresponded with the FDA and other agencies for many years on a number of different compliance activities covering the complete device life cycle, and has worked directly with the FDA, key opinion leaders and industry peers in the creation of a new performance standard for medical devices. For many years, the team has also served as FDA owner/operator, FDA Official Correspondent, and/or FDA U.S. Agent for multiple device establishments globally.
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Currently, the QNR team provides consulting services for companies within the medical device industry, with quality assurance and regulatory affairs / compliance as areas of focus.
Small, Streamlined and Efficient:
What Makes QNR Stand Out
We are a small consulting firm with its main office based in the Midwestern United States. Because of our low overhead and streamlined business model, we can pass savings onto our customers, giving them the time and attention that they deserve.
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The QNR team has learned through many years of experience, trial and error on how to best serve customers.
QNR Compliance: Our Commitment to You
Looking forward to the future, the team continues to grow its presence in the area of FDA compliance, and will serve as a reliable partner for your business. We look forward to hearing from you and discussing how we can serve your business and contribute to its success