What is ISO 13485:2016?
ISO 13485:2016 is an international standard that specifies requirements for a quality management system (QMS) where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and regulatory requirements. It focuses on the effectiveness of the QMS and emphasizes risk management and design control activities throughout the product lifecycle.
Benefits of ISO 13485:2016 Certification
- Enhances the quality and safety of medical devices
- Increases customer satisfaction and trust in your products
- Facilitates compliance with regulatory requirements
- Improves operational efficiency and reduces costs
- Encourages a culture of continuous improvement in quality management practices
Who Should Get ISO 13485:2016 Certified?
This certification is applicable to organizations involved in the design, development, production, installation, and servicing of medical devices. It is particularly relevant for manufacturers, suppliers, and distributors of medical devices, as well as organizations that provide related services.
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