ISO 13485 is a Management Systems Standard specifically developed for the manufacture of Medical Devices. Its primary objective is to facilitate harmonized medical device regulatory requirements. The standard contains specific requirements for manufacture, installation and servicing and calls for:
ISO 13485 contains requirements that are essential for any organization operating at any tier in the medical device and pharmaceutical supply chain. It is especially relevant to manufacturers that wish to demonstrate applicable regulatory requirements, and by organizations whose services support medical device manufacturers.
Informatics Consultant provides proven, proprietary implementation and training support to assure that your organization meets applicable ISO 13485 requirements promptly and effectively. A certified ISO 13485 Quality Management System will
Full Support provides everything in Basic Support, plus we will train and mentor an Internal Quality Audit team for your organization. Infomatics Management Consultant Pvt. Ltd. will witness your certification audit, if you choose. Everything we provide meets one or more ISO 13485 requirements, including a quality manual unique to your organization, acknowledging all ISO 13485 requirements (no "gap assessment" required) documentation and implementation support for your value added quality management system development of a simple, effective document and record control system training of an Internal Quality Audit Team, if you choose a mentored, full system audit of the new quality management system (no registrar "preliminary assessment" required) corrective/preventive action support from the full system audit recommendation for an economical, effective registrar, if you choose our witness of your registration audit, if you choose We take the time necessary to custom fit all applicable ISO 13485 requirements to your organization. No "consultant" is as willing and able as Infomatics Management Consultant Pvt. Ltd. to take the time to build a QMS to both reduce your costs and "pass the audit," guaranteed.
We selected informatics for our ISO 9001, ISO 14001 & ISO 45001 integrated management system after a rigorous selection process on the basis of their technical capabilities and project execution methodology. This was our first dealing with them but they were...
- Ali Haider
Al Hatimi Chemical Company
"Excellent company to work with. They were precise, professional and perfect. They made our ISO 9001 certification project very live, interesting and easy."
- Mohsin Hamez
Saudi Gulf Contracting Company