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
| Product Type | Medical Consulting |
| Primary Color | Blue |
| Services Offered | Turnkey |
| Regulatory Compliance | USFDA 510(k) |
| ISO Standards | 9001, 13485 |
| CE Marking | Yes |
| Project Phases | Land to FDA |
| Usage | Medical device projects: land selection through US FDA 510(k) approval. Includes layout, site monitoring, licensing, and ISO/CE compliance. |
| Features | Turnkey projects, FDA support, Regulatory guidance, Site monitoring, Licensing assistance |
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
OPERON STRATEGIST, Established in 2011 at Chinchwad in Maharashtra, is a leading service provider of Turnkey Projects in India. OPERON STRATEGIST is one of Trade India's verified and trusted names for listed services. With extensive experience in the field of Turnkey Projects, OPERON STRATEGIST has made a reputed name for itself in the market with satisfactory Disinfectant Qualification Services, GMDN Number Assessments, Hospitals Turnkey Project Consultant, etc.
Focusing on a customer-centric approach, OPERON STRATEGIST has a pan-India presence and caters to a huge consumer base throughout the country. Get Turnkey Projects from OPERON STRATEGIST at Trade India quality-assured services.
Focusing on a customer-centric approach, OPERON STRATEGIST has a pan-India presence and caters to a huge consumer base throughout the country. Get Turnkey Projects from OPERON STRATEGIST at Trade India quality-assured services.
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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