BEST CONSULTANT FOR MEDICAL DEVICES AND PHARMACEUTICAL REGULATORY, CDSCO, ISO, CE, ISI, USFDA, MDSAP, 510k, TGA AUSTRALIA & QUALITY MANAGEMENT SYSTEM CERTIFICATION

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ISO 13485 Certification

ISO 13485 Certification

ISO 13485 Certification

We have Experienced and Enthusiastic Professionals that help your Organization to get following Certifications for your Medical Devices from Accredited Certifying Bodies in Shortest possible Time and Cost-effective Way.

Quality Management System as per ISO 9001
Quality Management System for Medical Devices as per ISO 13485
Environment Management System as per ISO 14001
Indian Certification of Medical Devices- Technical Criteria for Certification of Medical Devices – ICMED 9000
Indian Certification of Medical Devices- Technical Criteria for Certification of Medical Devices – ICMED 13485

Our Team of Professionals help you in

Developing System of your Organization Infrastructure that Complies with Standards.
Developing Complete Documentation Procedures
Preparation of Technical Document for your Devices
Identifying Tests required for your Device
Assisting in Selection of Accredited Certifying Body
Assisting in Selection of Appropriate Notified Body
Assisting in Getting Certificate