ISO 13485:2016 Medical Devices Quality Management Systems

ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities.

ISO 13485:2016 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.

ISO 13485 Benefits

• ISO 13485 promotes harmonization of regulatory requirements for manufacturers of medical devices on an international scale.
• Demonstrate that you produce safer and more effective medical devices.
• Meet regulatory requirements and customer expectations.
• Outline how to review and improve processes across your organization.
• Meet regulatory requirements and customer expectations