ISO 13485 Quality Management System Certification for Medical Devices

ISO 13485 Quality Management System Certification for Medical Devices, may it be hardware or software used in treating human beings or in a diagnosis of diseases, have a significant effect on patient safety and risk management in medical business. Quality Management System based on ISO 13485 helps medical device manufacturers in reducing risks and in making better reliability. ISO 13485 is the most widely used for medical devices throughout the world. Successful design and manufacture of medical devices and supplies entails Quality Management System based on ISO 13485.


The standard ISO 13485:2012 was made particularly for restorative gadgets and supplies and depends on ISO 9001. The standard has been made into an instrument for the maker to use in making preconditions through which to provide food for the administrative wellbeing and execution necessities and also customer prerequisites at different phases of item life.


The standard does not give an immediate answer for outline quality. In any case it makes a structure which empowers the utilization of different arrangement models relying upon the one hand on maker size, the many-sided quality of the items and the potential dangers and on the other the quality targets set by makers themselves concerning both their own operations and the gadgets.


  • Benefits of ISO 13485 QMS Certification:

    • Improves risk management and reduces risks
    • Tool to develop management activities
    • Tool to ensure your business’s continuity
    • Tool to involve staff through risk management
    • Signal of reliability for your stakeholders
    • Improves efficiency