ISO 13485 is the internationally recognized and harmonized industry-specific quality management system standard designed for organizations involved in design and development, production, installation, servicing, and sales of medical devices. A certified organization proves its commitment to process approach in terms of the design, safety and quality of medical devices and its ability to provide medical devices and that related services consistently meet customer and applicable regulatory requirements.

• Improves your process quality
• Enables the documentation of compliance according to the relevant regulations
• Avoid costly product recalls by delivering consistent quality and safety
• Creates more trustworthy image to clients.
• Create a culture of continual improvement.
• Demonstrate commitment to safety and quality.
• Helps with more effective risk management.
• Serves as a basis for other regulatory frameworks and provides compliance with other regulatory systems.

For more information on certification process click here.