ISO 13485 – Medical devices system

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.

Some benefits of applying ISO 13485 to any institution:

  • 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.

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