Our Quality Management System allows us to provide and maintain the best value for our customers.


Meddux has developed a flexible and responsive QMS capable of handling the most critical aspects of medical device product development and manufacturing. Meddux is well suited to create and manage your product Design History File, Risk File, Device Master Record, and production Device History Records.

Our commitment to Quality starts with management and is shared by all employees.

The Meddux Quality Management System:

  • Built from the ground up with the customer’s needs and goals in mind

  • Offers a flexible compliant path through product development and manufacturing

  • 21 CFR 820 compliant

  • ISO 13485:2016 certified

  • ISO 14971:2012 compliant risk management process



Value Equation:


We are committed to:

  • Maintaining a constancy of purpose to improve

  • Providing exceptional value to customers based on speed, innovation, responsiveness and quality

  • Maintaining the highest level of compliance to all applicable regulatory standards

  • Delivering safe and effective medical devices to patients



ISO 13485:2016 Certification

Our QMS has been independently certified to ISO 13485:2016