Quality Management & Quality Control for Medical Devices

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 should 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:

• IEC 62304 Certification for Medical Device Software

• ISO 13485 Quality Management System for Medical Devices

• ISO 14971 Risk Management Requirements for Medical Devices 
• ISO 15378 Quality Management System for Medicinal Packaging Materials Suppliers

• Medical Device Single Audit Program (MDSAP)

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