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Noblitt & Rueland
5405 Alton Pky., 5A-530
Irvine, CA 92604-3718
Tel: 714/258-4646
Fax: 714/258-3990
E-mail: info@noblitt-rueland.com
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Description:
Offers FDA GMP/QSR and ISO audits, design control and software audits, design and software verification and validation, manufacturing/quality system software validation, electronic recordkeeping audits, risk and hazard analysis, and software/product development services. Also available is assistance with 510(k)/IDE/PMA and CE mark submissions. The company provides in-house training seminars for FDA/ISO software verification and validation for design/manufacturing, GMP/QSR, design control, risk and hazard analysis, ISO/CE mark, FDA inspections, and electronic recordkeeping.
Categories this company is listed under in the In Vitro Diagnostics Suppliers Directory:
- Consulting Services: Process Development and Validation (62 companies)
- Consulting Services: Product R&D, Design (74 companies)
- Consulting Services: Product Testing (68 companies)
- Consulting Services: Quality Systems Certification (53 companies)
- Consulting Services: Regulatory Affairs (74 companies)
- Consulting Services: Software Design, Programming (33 companies)
