ISO 13485, Medical devices – Quality Management Systems – requirements for regulatory purposes, is an internationally recognized standard for organizations involved in the medical device industry.  Companies are using compliance to this standard to obtain the certification of their Quality Management System. The primary purpose of the ISO 13485 standard is the Harmonization of the Medical Device regulatory requirements for Quality Management Systems.
Whether you are looking to operate internationally or expand locally, ISO 13485 Certification can help you improve overall performance, eliminate uncertainty, and widen market opportunities. Companies with this certification communicate a commitment to quality to both customers and regulators.

• Increase access to more markets worldwide with certification
• Outline how to review and improve processes across your organization
• Increase efficiency, cut costs and monitor supply chain performance
• Demonstrate that you produce safer and more effective medical devices
• Meet regulatory requirements and customer expectations