ISO 13485 is an internationally agreed standard that sets out the requirements for a quality management system specific to the medical devices industry.
ISO 13485 is designed to be used by organizations involved in the design, production, installation and servicing of medical devices and related services. It can also be used by internal and external parties, such as certification bodies, to help them with their auditing processes.
Safety and quality are must have features, both are non-negotiables in the medical devices industry. Regulatory requirements are stringent throughout any medical device’s product’s life cycle, including service and delivery. Thus, ISO 13485 is a prerequisite for access to most major markets worldwide. Having this certificate enhances the ease of business and provide access to a wider market.