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BesTech Consulting Services
28711 Jaeger Drive
Laguna Niguel, CA 92677 USA
Tel: +1 949 466 7472
Fax: +1 949 448 0312
E-mail: bestechconsulting@cox.net
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Description:
Provides regulatory affairs and product safety services for medical device companies. The company implements QSR and ISO quality systems, evaluates and tests products for IEC 60601 compliance and CE marking, and assists in submitting 510(k) premarket notifications, premarket approvals, IDE investigational device exemptions, and labelling compliance documentation.
Categories this company is listed under in the European Medical Manufacturing Suppliers Directory:
- Consultants: Auditing/Inspections (73 companies)
- Consultants: Conformity assessment (49 companies)
- Consultants: Equipment safety (23 companies)
- Consultants: Product certification (46 companies)
- Consultants: Quality assurance/Quality systems (118 companies)
- Consultants: Registration/Submission assistance (61 companies)
- Consultants: Regulatory (113 companies)
- Consultants: Risk management (60 companies)
- Consultants: Start-up assistance (65 companies)
- Consultants: Technical documentation (85 companies)
