Preparing for the New Quality Management System Regulation (QMSR)

Whitepaper | March, 2023

FDA’s QSR and ISO 13485 were first published around the same time in 1996. But, while ISO 13485 has been revised five times till now, the QSR has remained more or less the same. The alignment with ISO 13485 is expected to make FDA regulations on par with the internationally accepted regulatory expectations for QMS for devices but will continue to be under the FDA jurisdiction.

The ISO 13485 standard enables medical device manufacturers to incorporate best practices for manufacturing by establishing a set of interrelated requirements to create a quality management system. Implementing ISO 13485 can help medical device manufacturers maintain medical-grade quality, improve customer satisfaction and achieve continual improvement.

By getting certified for this regulation, entry into international markets and customer acquisition will become easier. This standard is also recognized by the EU, thereby reducing the burden on US manufacturers to comply with the EU MDR QMS requirements.

ISO 13485 implementation will help manufacturers produce high-quality and safe products. They will gain insights into potential risks during the product development process, enabling them to proactively address and correct them. It will also improve inspection and traceability measures for all medical devices.

This standard also emphasizes the importance of setting up specialized processes for sterile medical devices and strict adherence to cleanliness requirements.

In this whitepaper, we talk about:

  • Benefits of ISO 13485
  • Harmonizing QSR with ISO 13845
  • QMSR vs QSR
  • And more

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