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A Stein, Regulatory Affairs Consulting
Beit Hapa'amon (Box 124), 20 Hata'as Street
Kfar Saba, IL-44425 Israel
Tel: +972 9 767 0002
Fax: +972 9 766 8534
E-mail: asteinra@netvision.net.il
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Description:
Provides US FDA regulatory services for medical device manufacturers, including regulatory documentation preparation and submissions (pre-IDE, IDE, 510(k), and PMA). In addition, the company's services comprise clinical studies management according to GCPs; quality system implementation and auditing to assess compliance with FDA QSR requirements and ISO 13485 standards; and European regulatory services, including compliance with MDD 93/42/EEC requirements, technical file preparation, and more.
Categories this company is listed under in the European Medical Manufacturing Suppliers Directory:
- Consultants: Auditing/Inspections (67 companies)
- Consultants: Clinical research (28 companies)
- Consultants: Clinical trials management (42 companies)
- Consultants: Conformity assessment (43 companies)
- Consultants: Product certification (43 companies)
- Consultants: Quality assurance/Quality systems (105 companies)
- Consultants: Registration/Submission assistance (53 companies)
- Consultants: Regulatory (105 companies)
- Consultants: Risk management (50 companies)
- Consultants: Technical documentation (72 companies)
