ISO 13485 : 2016 – Quality Management System- Medical Devices
ISO 13485- QMS – Medical Devices is an international standard that defines the requirements for the Quality Management system for the manufacturers, contract services, suppliers, distributors of the medical devices.
The basis for ISO 13485 is ISO 9001 standard and the same is structure is referred for ISO 13485 completion. The ISO 13485 standard for the medical devices- Quality management system- Requirements for regulatory purpose, is one of the major basis for the regulatory compliance in the local and most of the international markets. ISO 13485 Certification is mandatory for the companies who are into the export of medical devices to other countries. The main objective of the standard is to bring harmony between the legal requirements and the management system being followed to manufacture or trade the medical devices.
Benefits:
- 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