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Quality management and medical devices

Learn about quality management systems and medical devices.

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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 links

Quality, safety, and performance requirements for medical devices (the Essential Principles)
Obtain and maintain regulatory evidence
Quality Management System audits and nonconformities
Product types
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