Morgan Scientific, Inc. is proud to be certified to ISO 13485

ISO 13485 is an ISO standard, published in 2003, that represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices.

Specific focus includes:

  • the promotion and awareness of regulatory requirements as a management responsibility. An example of market specific regulatory requirements is 21 CFR 820 Quality System Regulation for Medical Devices sold in the United States.
  • controls in the work environment to ensure product safety
  • focus on risk management activities and design control activities during product development
  • specific requirements for inspection and traceability for implantable devices
  • specific requirements for documentation and validation of processes for sterile medical devices
  • specific requirements for verification of the effectiveness of corrective and preventative actions