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European Medical Manufacturing Suppliers Directory Index
Noblitt & Rueland
5405 Alton Parkway 5A, #530
Irvine, CA 92604 USA
Tel: +1 714 258 4646
Fax: +1 714 258 3990
E-mail: info@noblitt-rueland.com
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Description:
Offers specialised consulting expertise in FDA- and ISO-related issues such as GMP, QSR, QSIT, audits, submissions (510(k), IDE, PMA, CE mark), design control, risk assessment, hazard analysis, software quality assurance, software compliance audits, independent verification and validation, product and software development, electronic recordkeeping (21 CFR Part 11), and FDA 483s and warning letters.
Categories this company is listed under in the European Medical Manufacturing Suppliers Directory:
- Certification Bodies and Notified Bodies: Quality management certification services (47 companies)
- Consultants: Auditing/Inspections (67 companies)
- Consultants: Conformity assessment (43 companies)
- Consultants: Quality assurance/Quality systems (105 companies)
- Consultants: Reference/Educational materials (11 companies)
- Consultants: Registration/Submission assistance (53 companies)
- Consultants: Regulatory (105 companies)
- Consultants: Risk management (50 companies)
- Consultants: Training services (84 companies)
- Testing: Testing services: Validation (40 companies)
