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Quality and Regulatory Services Inc.
1244 Fairway Valley Ct.
Lincoln, CA 94596
Tel: 916/645-7008
Fax: 916/645-7038
E-mail: bob@qrs-i.com
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Description:
Provides compliance solutions to meet all aspects of CDRH/FDA requirements and ISO quality systems. Capabilities include IDEs, PMAs, 510(k)s, QSR/GMP implementation and audits, training, process validation, radiological health, FDA-483, and warning letter recovery. The principals have experience at FDA, in medical institutions, and with international manufacturers.
Categories this company is listed under in the In Vitro Diagnostics Suppliers Directory:
- Consulting Services: Process Development and Validation (62 companies)
- Consulting Services: Quality Systems Certification (53 companies)
- Consulting Services: Regulatory Affairs (73 companies)
