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Quality management and medical devices

Learn about quality management systems and medical devices.

Manufacturers of medical devices must ensure their medical devices consistently meet safety, performance, and quality requirements.

Manufacturers of certain medical devices must put in place a formal Quality Management System (QMS) and have the system independently certified.

Key information

Learn about quality management systems

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Learn about Quality Management Systems and how medical device manufacturers use them to meet their regulatory and customer requirements.

Related information

Quality, safety, and performance requirements for medical devices (the Essential Principles)

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Medical devices must comply with the Essential Principles. These set out fundamental safety and performance requirements.
Obtain and maintain regulatory evidence

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Understand what evidence is needed to have a medical device included in the Australian Register of Therapeutic Goods (ARTG).
Manufacture specific types of medical devices

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Information and guidance on the regulation and manufacture of specific types of medical devices.
Quality Management System audits and nonconformities

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Gain an understanding of commonly identified nonconformities during TGA audits

Topics