Medical Device Consultant

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.