ISO 13485 quality system for medical device production

13485 is an important quality system for establishments that produce medical devices and/or all related medical supplies. It is a recognized international quality system and the European Conformity Mark; -CE- no one can obtain without applying this ISO Quality standard.
The ISO 13485 the management of quality system for medical device production requires:
a quality system that specifies regulatory requirements, risk management and supplier controls, as well as design, manufacture and production processes.
It is also a quality system, that establishes an important set of definitions and terms, that manufacturers of medical devices and supplies should take care off.

  • Having access to markets that recognize or require certification including Canada and Europe.
  • The application of a quality management system in general assists to motivate employees and provide a better definition of the main roles and responsibilities.
  • Reducing operational costs by highlighting process shortcomings and improving efficiency.
  • Increase customer satisfaction by providing high-quality products and regularly handling complaints.
  • Demonstrating a commitment to quality by applying an internationally recognized standard.
  • Adding transparency to the way of dealing with complaints, how to monitor or handle returned products.