Medical Devices Quality Management System (MDQMS)

ISO 13485

ISO 13485 is an international standard specifying some particular requirements for the organizations engaged in manufacturing and processing of medical devices. The quality management system for medical devices manufacturing and processing involves some particular requirements for the organizations with an intent for promotion and awareness of regulatory requirements as a management responsibility. It also provides framework for specific requirements for identification, traceability and validation of process for implantable medical devices and sterile medical devices.ISO 13485 is now considered to be inline standard and requirement for medical devices even with "Global Harmonization Task Force Guidelines" (GHTF).The GHTF guidelines are slowly becoming universal standards for design, manufacture, export and sales of various medical devices. The GHTF has been replaced in the last few years by the International Medical Device Regulatory Forum (IMDRF) and is structured differently from the GHTF as only the regulators, that are primary members of the group, get to make many of the decisions. The IMDRF main membership (the regulators) do want to have non-regulators involved without voting rights and in this way they are hoping to get the process and documents completed quicker than under the GHTF system.

Some key benefits for certification to ISO 13485 are :

  • Faster Cycle Times
  • Waste Reduction
  • Systematic Process Improvement
  • Enhanced Customer satisfaction
  • Effective Regulatory Compliance
  • Employees satisfaction and motivation
  • Cost Effective process
  • Efficiency Increased
  • Product safe environment