Medical Device Consultant
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Product Specifications
| Service Type | Consulting |
| Regulatory Compliance | USFDA, CE, WHO |
| Standards Adherence | ISO 9001, ISO 13485 |
| Expertise Areas | GMP, Validation |
| Project Scope | Turnkey Projects |
| Usage | Medical device regulatory compliance, quality systems implementation, and training. |
| Deliverables | Reports, documentation |
| Features | Regulatory Support, Quality Systems, Compliance Expertise, Training Provided, Vendor Audits |
Product Overview
Key Features
Medical Turnkey Project:
Facility (Plant) Design
Facility (Plant) built up
Regulatory Liasoning
Medical device Consultant
Regulatory
USFDA 510 (k)
510 K file preparation
File submission
Establishment registration and device listing
US agent appointment
Medical Devices
China FDA registration
GMDN number assessment
US agent appointment
EU Agent appointment
Quality Assurance
Current Good Manufacturing Practises (cGMP):GAP ANALYSIS and Implementation as per requirements of
USFDA ( 21 CFR Part 820)
Europe (CE requirements)
WHO-GMP
CDSCO (Indian FDA)
ISO 9001 : 2008 Consultant
ISO 13485 : 2003 Consultant
Quality Assurance
Audit Compliance of
USFDA (21 CFR Part 820)
Europe ( CE requirements)
WHO-GMP
CDSCO ( Indian FDA)
ISO 9001 : 2008
ISO 13485 : 2003
CAPA Management System
Change Management System
Validation
Equipment Validation
Utility Validation
Microbiological Validation
Process Validation
Cleaning Validation
Analytical Method Validation
Certifications
ISO 9001 : 2008 : Quality management System
ISO 13485 : 2003 : Quality management system - Medical devices.
Training
Current Good manufacturing Practises.
Equipment And Utility Validations
Microbiological Validation
Cleaning Validation
CAPA Management System
Change Management System
Third Party vendor audits
Third Party vendor audits on behalf of Company.
Facility (Plant) Design
Facility (Plant) built up
Regulatory Liasoning
Medical device Consultant
Regulatory
USFDA 510 (k)
510 K file preparation
File submission
Establishment registration and device listing
US agent appointment
Medical Devices
China FDA registration
GMDN number assessment
US agent appointment
EU Agent appointment
Quality Assurance
Current Good Manufacturing Practises (cGMP):GAP ANALYSIS and Implementation as per requirements of
USFDA ( 21 CFR Part 820)
Europe (CE requirements)
WHO-GMP
CDSCO (Indian FDA)
ISO 9001 : 2008 Consultant
ISO 13485 : 2003 Consultant
Quality Assurance
Audit Compliance of
USFDA (21 CFR Part 820)
Europe ( CE requirements)
WHO-GMP
CDSCO ( Indian FDA)
ISO 9001 : 2008
ISO 13485 : 2003
CAPA Management System
Change Management System
Validation
Equipment Validation
Utility Validation
Microbiological Validation
Process Validation
Cleaning Validation
Analytical Method Validation
Certifications
ISO 9001 : 2008 : Quality management System
ISO 13485 : 2003 : Quality management system - Medical devices.
Training
Current Good manufacturing Practises.
Equipment And Utility Validations
Microbiological Validation
Cleaning Validation
CAPA Management System
Change Management System
Third Party vendor audits
Third Party vendor audits on behalf of Company.
Company Details
OPERON STRATEGIST, Established in 2011 at Chinchwad in Maharashtra, is a leading service provider of Medical Services in India. OPERON STRATEGIST is one of Trade India's verified and trusted names for listed services. With extensive experience in the field of Medical Services, OPERON STRATEGIST has made a reputed name for itself in the market with satisfactory Medical Device 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 Medical Services 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 Medical Services 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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