ISO 13485 Medical Devices QMS

QHSE Management System Standards

ISO 13485 Medical Devices QMS

Welcome to OrientMCT

At OrientMCT , we are dedicated to ensuring the highest standards of quality and safety in the medical devices we provide. Our commitment to excellence is reflected in our adherence to the ISO 13485:2016 standard for Quality Management Systems (QMS) for Medical Devices.

ISO/IEC 17024 Conformity Assessment

What is ISO 13485?

ISO 13485 is an internationally recognized standard that sets the requirements for a comprehensive quality management system specific to the medical device industry. It ensures that organizations establish, implement, and maintain processes that consistently meet customer and regulatory requirements.

Our Commitment to Quality

  • Stringent Processes: We have implemented robust processes throughout our organization to ensure the quality and safety of our medical devices.
  • Compliance: Our QMS aligns with ISO 13485, demonstrating our commitment to complying with regulatory requirements and meeting customer expectations.
  • Continuous Improvement: We are dedicated to continuous improvement, regularly reviewing and enhancing our processes to provide the best products and services to our customers.

Key Components of Our QMS

1. Management Responsibility

Our leadership team is actively involved in the establishment and maintenance of our QMS, ensuring that quality objectives are defined, communicated, and understood at all levels of the organization.

2. Resource Management

We invest in the necessary resources, including skilled personnel and state-of-the-art facilities, to consistently deliver high-quality medical devices.

3. Product Realization

From design and development to production and delivery, our processes are carefully controlled to meet product specifications and regulatory requirements.

4. Measurement, Analysis, and Improvement

We employ a systematic approach to monitoring and measuring key aspects of our QMS, allowing us to identify opportunities for improvement and take corrective actions when necessary.

Get In Touch!

Contact us for a quote or in case of any urgent queries please send us an email on: info@orientmct.com
we will get back to you right away!

7th Floor - Al Otaiba Tower