​ISO 13485 is an internationally agreed standard that sets out the requirements for a quality management system specific to the medical devices industry. These are mainly referring to product safety, detailed documentation and burden of proof as well as the development of risk management.

ISO 13485 is designed to be used by organizations involved in the design, production, installation and servicing of medical devices and related services.

​​Key benefits

Minimize and Controls Risks

Increase Efficiency and Better Cost Management

Develop Corporate Image and Credibility

Meet Regulatory Requirements