Medical Device Qualified Supplier Directory

 

Quality and Regulatory Services Inc. Company Profile

T: 925/787-2421
F: 916/408-4603

Address
1244 Fairway Valley Ct., Lincoln, CA, 95648, United States
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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.

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T: 925/787-2421
F: 916/408-4603

Address
1244 Fairway Valley Ct., Lincoln, CA, 95648, United States
View map