ISO 13485:2016 Medical Devices Quality Management Systems

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Safety and quality are non-negotiable in the medical devices industry because service lapse could impact human lives. In this regard, ISO 13485 establishes requirements for comprehensive quality management for the design and manufacturing of medical devices. It is a stand-alone QMS standard accepted as for ISO 9000 quality management standard series. It adapts the ISO 9000 process-based model for a regulated medical device manufacturing environment. The standard is more prescriptive in nature and requires a more thoroughly documented quality management system.

BENEFITS OF ISO 13485:2016 STANDARD

  •          Improved company’s reputation as the certified organizations perceived as self-conscious and responsible for the quality of medical devices manufactured for its customers.

  •          Improved and stronger decision-making based on established facts & figures demonstrated the safety of the produced medical devices.

  •          Better compliance with regulatory requirements and ensured customer satisfaction.

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