New World Regulatory Solutions (NWRS) has seasoned professionals with decades of experience in regulatory affairs, clinical studies, quality systems, risk management and human factors for the medical device and in vitro diagnostics industry.
We provide superior, custom-tailored strategies for you to successfully bring your diagnostic innovations into the US and worldwide healthcare market. We help companies achieve ISO and CE mark certification for their products.
NWRS was founded in 2002 with the mission of helping domestic and international companies gain regulatory approval for innovative medical devices.
NWRS embraces a total life cycle approach to product development and risk management to provide sound guidance and hands-on support from the concept stage through development, commercialization and post market issues.
The NWRS staff consists of success-oriented individuals with senior level backgrounds and proven track records in the professional and home-use in vitro diagnostics industry.
The staff’s professional careers include experience at entrepreneurial start up and publicly traded fortune 500 companies. NWRS staff members have served on industry trade organization committees that help establish regulatory policy in the diagnostics industry.
NWRS’ combined years of experience in the diagnostics industry has been rewarded with the opportunity to work alongside the world’s leading experts in the medical, scientific, regulatory and clinical arenas.
Key Personnel Include:
- Maureen Garner, MS, MT (ASCP), ASQ CQA, President
- Glenn Neuman, MS, Director of Scientific Affairs
- Suzan Fenichel, MT (ASCP), Manager, Regulatory/Clinical
- Katrina Fiedler, BS, ASQ CQA, RAPS RAC-US, Director, Quality System/Compliance
Maureen, Glenn and Katrina worked together for over 10 years at Carter-Wallace, a pharmaceutical, OTC, medical diagnostic products company, combining their regulatory, compliance and technical expertise, which is favorably received by regulatory bodies.
Glenn and Maureen’s strategic skills have produced industry firsts in CLIA waiver status for rapid point-of-care tests for mononucleosis and Lyme disease.
Maureen was also instrumental in gaining the first sooner than missed period claim for a widely distributed OTC pregnancy test, which helped to double the brand sales in 2001 and moved the product to the #2 pregnancy test on the market with a 12.3% market share.
Katrina has extensive experience and a successful track record in custom-designing, analyzing, auditing Quality Systems for FDA/QSR and ISO compliance, international product registrations/licensing/CE marking, and in global post market surveillance compliance matters ( e.g. complaint handling, recalls, medical device/vigilance reporting).
Maureen and Suzan worked together for a total of 5 years at two different start-up in vitro diagnostic companies specializing in POL and point-of-care medical devices intended for laboratory professionals and lay users, where they concentrated their efforts in building up and expanding the Technical Services and Training departments.
Maureen, Glenn and Katrina are active members of the Regulatory Affairs Professional Society (RAPS) and the American Society for Quality (ASQ), Association Medical Diagnostic Manufacturers (AMDM), and Maureen served on the In-Vitro Diagnostics and CLIA Task Forces at AdvaMed.
Katrina is RAC-US certified and both Katrina and Maureen are ASQ Certified Quality Auditors.
There are many aspects to a successful market entrance for new diagnostic tests. Any device that successfully passes through the US FDA pre-market review was designed to meet that goal.
NWRS experience with the FDA has resulted in a proven record of success in obtaining device approvals and granting of CLIA waiver status for our clients’ products.
How to Get FDA Approvals
Download our presentation on managing regulatory issues and get FDA approvals.