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Quality Management & Quality Control for Medical Devices

Efficient medical device quality management and testing

extensive experience in the field of medical device quality management

To gain access to markets with the most rigorous standards for medical devices and medical quality control, you need to ensure your products maintain the highest standards. By certifying your design, production and distribution processes, medical device quality management proves to regulators and buyers alike that your product is of the highest standard – thereby fostering trust and boosting your reputation.

Our quality management auditing certificates indicate compliance with a wide range of international standards such as ISO 13485. This is proof that your products have been manufactured against the highest medical quality control standards.

Learn more about our auditing, testing and training services for medical device quality management below:


ISO 13485 Quality Management System for Medical Devices
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ISO 13485 QMS for Medical Devices

Fulfill the requirements of ISO 13485:2016 with expert guidance

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ISO 13485:2016 Revision

ISO 13485:2016 Revision Fact Sheet

A quick guide to the revised ISO 13485:2016 standard

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ISO 9001 & ISO 13485 – How Do These Standards Relate and Differ?

ISO 9001 & ISO 13485 – How These Standards Relate and Differ

Discover the similarities and differences between the two standards

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