ISO 13485 (Medical Devices)

ISO 13485 – Medical Device – Quality Management Systems –Requirements for regulatory purpose – address the development, implementation and maintenance of quality management system intended for use by medical device manufacturers, developers, and suppliers. The standard details the requirement for quality management systems, to meet customer requirement and allows the incorporation of applicable regulatory requirements within an organization’s quality management system.

Learning Objective:

  • Basic Introduction to ISO 13485: 2016
  • Relation ISO 9001:2015 / ISO 13485:2016
  • Key issues addressed by ISO 13485:2016
  • Integration of Risk Management ISO 14971 in ISO 13485