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Noblitt & Rueland
5405 Alton Pky. 5A, #530
Irvine, CA 92604 USA
Tel: 714/258-4646
Fax: 714/258-3990
Contact: Dennis Rubenacker
Year Established: 1989
No. of Employees: 15
Key Clients: Baxter, Johnson & Johnson, Abbott, Beckman, Boston Scientific.
Web: http://www.fdaconsulting.com
E-mail: info@fdaconsulting.com
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Description:
Noblitt & Rueland offers specialized consulting expertise in FDA and ISO related issues such as GMP-QSR-QSIT, ISO 13485:2003, audits, electronic recordkeeping (Part 11), submissions (510(k), IDE, PMA, CE mark, design control, risk management, hazard analysis, software quality assurance, software compliance audits, independent verification and validation, testing, software development, 483 and warning letter assistance, and extensive in-house training.
Categories this company is listed under in the Consultants Directory on Medical Device Link:
- Audits/Inspections (43 companies)
- Clinical Research (19 companies)
- Educational Materials (4 companies)
- Electromagnetic Compliance (8 companies)
- Europe: Marketplace/ Regulations (25 companies)
- Good Manufacturing Practices/Compliance (53 companies)
- Outsourcing Services (22 companies)
- Process Validation (32 companies)
- Quality Assurance (47 companies)
- Quality Management (21 companies)
- Quality Systems Certification (15 companies)
- Regulatory Affairs (51 companies)
- Reliability Engineering (5 companies)
- Safety (11 companies)
- Software/Hardware Development (21 companies)
- Strategic Planning (24 companies)
- Training (33 companies)
