Medical Device Qualified Supplier Directory
Quality and Regulatory Services Inc. Company Profile
1244 Fairway Valley Ct., Lincoln, CA, 95648, United States
Markets Supplied: North America, Europe
Contact: Robert J. Morton
Year Established: 1994
No. of Employees: 4Quality and Regulatory Services Inc. provides compliance solutions to meet all aspects of CDRH and FDA requirements and the ISO 13485 quality systems standard. The firm's capabilities include IDEs, PMAs, 510(k)s, QSR and CGMP implementation and audits, training, process validation, radiological health issues, U.S. agent services, and FDA-483 or warning letter recovery. The principals have experience at FDA, in medical institutions, and with U.S. and international manufacturers.