ISO 13485:2016 Quality Management System for Medical Devices In UAE
ISO 13485 is a Management Systems standard specifically developed for the manufacture of medical devices published by the International Organization for Standardization in 2003 and revised in 2016. The standard provides a framework for a comprehensive management system for the design and manufacture of medical devices. Its primary objective is to facilitate harmonized medical device regulatory requirements. 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 who wish to demonstrate applicable regulatory requirements, and by organizations whose services support medical device manufacturers.
How to hire ISO 13485 Consultant in UAE
ISO 13485 consultant in UAE is a qualified lead auditor who will provide training, implementation, documentation, internal audit and certification audit assistance services for an effective & result oriented ISO 13485:2016 medical devices quality management system implementation. Organizations can contact ISO 13485 consultant in UAE by calling +971 505842597 or sending an email at info@uaeiso.com
Benefits of ISO 13485:2016 in UAE :
- Customer satisfaction
- Reduced operating costs
- Improved stakeholder relationships
- Legal compliance
- Improved risk management
- Proven business credentials
- Ability to win more business
Deliverables of ISO 13485:2016 Consultants in UAE
- Implementation of a quality management system with several enhancements
- Risk management approach to product development and product realization
- Validation of processes
- Compliance with statutory and regulatory requirements
- Effective product traceability and recall systems
- Medical devices technical file
Our Services
We offer comprehensive services that will help you achieve your ISO 13485:2016 quality goals. We provide assistance to:
- Conduct an initial gap analysis
- Help you establish policies and objectives
- Identify documentation requirements
- Make assignments and prepare schedules
- Prepare documentation
- Coordinate document preparation, reviews, approvals, and production
- Manage implementation schedules, training, follow-up actions
- Help you seek accreditation certificate for ISO 13485:2016
In addition to consulting (online and onsite), we provide the following training :
- ISO 13485 Overview Training
- ISO 13485 for the small laboratory
- Development of medical devices quality system documentation
- Internal auditor training
- ISO 13485 implementation training
