ISO 13485 specifies requirements for a Quality Management System for organizations required to demonstrate its ability to provide medical devices that consistently meet client and regulatory requirements.
ISO 13485 provides proof that your company is providing safe and effective medical devices.
Safety and quality are non-negotiable in the medical devices industry, that’s why we developed ISO 13485.
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.
ISO 13485 is the most accepted global standard of its kind and will bring your business a host of benefits, including:
> Legal Compliance
> Enhanced Reputation
> Improved efficiency
As a medical devices manufacturer, you have a responsibility and requirement to consistently deliver devices that are high quality, safe and effective. The medical device industry is made up of many different and complex regulations, standards and other requirements.
The medical device standard, ISO 13485, helps manufacturers to become compliant and open up market channels on a global scale.
“ISO 13485 Certified” means an organization has implemented an ISO 13485 Quality Management System and has successfully met all of the requirements in ISO 13485. ISO 13485 evaluates whether your Quality Management System is appropriate and effective while emphasizing the safety and efficacy of medical devices.