Skip navigation links
Free Quote Request
ISO Trainings
Contact Us
Skip navigation links
About UsExpand About Us
Internal/Supplier Audits (2nd Party Audits)
StandardsExpand Standards
Client Directory
ResourcesExpand Resources
Auditor TrainingExpand Auditor Training
ISO 13485:2003 

ISO 13485 specifies requirements for a quality management system for medical devices and related services that demonstrates consistency and facilitates the harmonization of medical device regulatory requirements. ISO 13485 provides for controls in the work environment to ensure product safety, focuses on risk management activities and design transfer activities during product development and specifies requirements for verification of the effectiveness of corrective and preventive actions.

For more information contact us at: or 1-877-4MYISO1 (469-4761)