ISO 13485 - Medical Devices Quality Management System, MDQMS

ISO 13485 - Medical Devices Quality Management System (MDQMS)

Any device or apparatus which is related to health care industry but don't have pharmaceutical action capabilities, is called "Medical Device". Medical devices can be a simple thermometer, micro chip based technology, laser surgical tool, apparatus used in operation etc.

ISO 13485 pin points requirements of Quality Management System (QMS) for any medical device manufacturing organization. As per these requirements the organization have to meet customer's satisfaction consistently and also to comply with regulatory requirements. These organizations are usually involved in two or more steps out of design, development, production, distribution, maintenance, storage and installation of medical devices.

ISO 13485 emphasizes on medical devices manufacturing industry's regulatory requirements. Medical Devices Quality Management System Standard focuses on risk factors and monitors the overall product development process. This standard outlines requirements and procedures that are necessary for manufacturing a specific medical device.

Benefits of ISO 13485 / Medical Devices Quality Management System

  • Helps winning customer's confidence
  • Helps meeting customer's expectations
  • Helps minimizing communication gaps
  • Helps improve efficiency
  • Helps build supplier's relationship
  • Helps introducing safe and effective medical devices.