Consultant - Medical Consulting | Turnkey Projects From Land Selection To Usfda 510(k) With Iso 9001, 13485 And Ce Marking Compliance
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Product Specifications
| CE Marking | Yes |
| Features | Turnkey projects, FDA support, Regulatory guidance, Site monitoring, Licensing assistance |
| ISO Standards | 9001, 13485 |
| Primary Color | Blue |
| Product Type | Medical Consulting |
| Project Phases | Land to FDA |
| Regulatory Compliance | USFDA 510(k) |
| Services Offered | Turnkey |
| Usage | Medical device projects: land selection through US FDA 510(k) approval. Includes layout, site monitoring, licensing, and ISO/CE compliance. |
Product Overview
Key Features
Medical device consultant for the turnkey projects right from the Land selection to the USFDA of the product.
This includes but not limited to :
Layout preparation
Facility site monitoring
Local FDA licencing
ISO 9001
ISO 13485
CE marking
USFDA 510 (k)
Company Details
Established in 2011, OPERON STRATEGIST has made a name for itself in the list of top service providers of Turnkey Projects in India. OPERON STRATEGIST is listed in Trade India's list of verified companies offering a wide array of Disinfectant Qualification Services, GMDN Number Assessments, Hospitals Turnkey Project Consultant, etc. Contact here for Turnkey Projects in Chinchwad, Maharashtra.
Business Type
Service Provider
Employee Count
10
Establishment
2011
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Seller Details
Chinchwad, Maharashtra
Name
Mr. Anil Chaudhari
Address
Office - P-511, Mayur Trade Centre, Phase-1, Chinchwad Station, Chinchwad, Maharashtra, 411033, India
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