ISO 13485:2003 Medical Devices Quality Management System

ISO 13485:2003 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.

All requirements of ISO 13485:2003 are specific to organizations providing medical devices, regardless of the type or size of the organization.

Benefits of ISO 12485:2003

• Quality Management System which maintains compliance to the requirements of the medical device industry and is in line with the FDA QSR standards.
• Improved manufacturing controls and procedures that ensure safe and effective medical devices.
• Greater assurance that product will continue to meet customer specifications.
• Improved Risk Management and Design Controls to assist customers in the development and improvement of their products.
• Improved efficiency in assisting customers obtain market clearance and approval to meet aggressive sales and marketing goals.”