iso 13485
Medical Device Quality Management Systems.
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ISO 13485 Consultancy
We should provide innovative solutions, based on your strategic objectives, to better meet your needs.
ISG consultants are ready to provide their expertise, which extends for more than 15 years in assisting all types of industrial, commercial and service companies in all Arab countries to apply the standards of Medical Device Quality Management Systems. ISO 13485,and obtain the ISO certification, Through our work we will be with you step by step to build an effective Quality Management System that meets international standards and helps you monitor the planning, delivery and implementation of services and products and identify performance indicators and quality standards to be monitored.
BENEFITS OF ISO 13485 CERTIFICATION
Implementing ISO 13485 will have many benefits for your organization. Although changes in your QMS will take immediate additional energy, the results of having an ISO 13485 quality management system will provide you with many benefits in operations, sales, and customer satisfaction.
- Organization demonstrates compliance with current legal requirements.
- Medical Devices – Mandatory to use CE marking on products
It certifies that it works in accordance with an internationally recognized standard
expands. - Provides advantage and prestige over competitors.
- Reduces customer complaints.
- Reduces product defects.
- Increases profitability.
- Gain export advantage.
- Top management systematically monitors the organization’s activities.
- Detects disruptive aspects of the system, gives the opportunity to correct.
- Increases customer satisfaction.
- Ensures the continuity of the efficiency of the existing system
Result:
The ISO 13485 certification supports medical device manufacturers in plotting a QMS that creates and maintains the efficacy of their processes. It ensures the consistent design, development, production, installation, and delivery through to the disposal of medical devices that are safe for their intended purpose. businesses, you’ll find that your employee engagement and retention increases. Your managers will feel more in control as processes are improved and as your new framework for best practice is implemented.
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