NUORTHO SURGICAL Working with Regulatory Expert For FDA Filing
Fall River, MA, March 23, 2010 – NuOrtho Surgical, Inc., a developer of leading edge surgical instruments, announced it has retained the services of RA/QA International L.L.C. for assistance in completing the 510K FDA regulatory filing for the Ceruleau™ orthopedic probe. RA/QA, headed by Martin Leighton, has been assisting companies with domestic and international regulatory submissions since 1996.
“Martin and his firm bring a wealth of knowledge and experience to us as we finalize our regulatory submission for our product Ceruleau™ which is designed to remove damaged cartilage and preserve healthy tissue during surgery.” said NuOrtho CEO, Jeff Morrill. “This is the first product of many we are developing for our Tissue Preservation™ platform and it was important for us to partner with one of the best in completing our FDA submission. RA/QA provides another quality regulatory resource to our team and they will help ensure that we provide the FDA with a thorough and robust filing.”
RA/QA’s Martin Leighton commented “I am pleased to be working with NuOrtho on this submission. The more I learned about their Tissue Preservation™ platform and their products, the more involved I wanted to be with this innovative company.”
Martin Leighton, Principal of RA/QA International is a Bio-Medical Engineer and was formerly Executive Director of Operations and Strategic Business Development for the US Medical Division of TÜV Product Service, a Division of TÜV America, Inc. Martin has worked with companies such as Agilent Technologies (now Phillips Medical, formerly HP Medical Products), Chiron Vision, Alcon, Bausch & Lomb, Teleflex Medical/Arrow Int., Baxter, Colorado MEDtech, Genzyme, Hill-Rom, Johnson & Johnson, Medtronic, MedSource, Siemens, Smith + Nephew, Respironics, TYCO (Sherwood, Davis+Geck, USSC), C. R. Bard, Bristol-Myers Squibb Medical Imaging and many more.
RA/QA International provides hands-on consulting services to the medical devices industry for regulatory submissions, compliance and quality management systems. Recently RA/QA International, L.L.C. has also added ISO 14644 clean room certification services to its product offering
Martin was trained at the FDA’s Staff College for “Pre-market Notification 510(k) Review for Third Party Organizations” and “Quality System Regulation (QSR)-Design Controls Assessments.”
NuOrtho Surgical is focused on the manufacture of surgical instruments that enable Tissue Preservation™ in the orthopedic arena to improve patient outcomes. NuOrtho has three primary product platforms for preserving healthy tissue to sustain long-term mobility. These platforms include Soft Tissue Treatment, Agent Delivery and Bone Fusion. NuOrtho’s first product launch will be Ceruleau™, a revolutionary product for soft tissue treatment in knee procedures for cartilage. The company has nine patents providing significant business opportunities. For further information visit www.nuortho.com.