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Quality and Regulatory Services Inc.
1244 Fairway Valley Ct.
Lincoln, CA 95648
Tel: 925/787-2421
Fax: 916/408-4610
Contact: Robert J. Morton
Year Established: 1994
No. of Employees: 4
Web: http://www.qrs-i.com
E-mail: solutions@qrs-i.com
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Description:
Quality 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.
Categories this company is listed under in the Consultants Directory on Medical Device Link:
- Audits/Inspections (43 companies)
- Good Manufacturing Practices/Compliance (53 companies)
- Process Validation (32 companies)
- Quality Assurance (47 companies)
- Quality Management (21 companies)
- Regulatory Affairs (51 companies)
- Training (33 companies)
