Companies that trade medical devices are required by virtue of Ministerial Decision Ε3/833/1999 to have their Quality Management System certified. ISO 13485:2003 is based on the principles of ISO 9001:2008 and is specially designed for medical device companies. The aim of this Quality Management System (QMS) is to ensure:

  • Compliance of the firm to the existing Legislation
  • Development of a Quality Management System with documents, files and a manual
  • Creation of a suitable environment and company operation ensured by specialised personnel
  • Interaction with customers to ensure satisfaction

The benefits of the adoption of a Management System are the following:

  • Cost reduction
  • Higher customer satisfaction and improved reputation of the company in the market
  • Increased productivity
  • Increased satisfaction of employees
  • Continuous improvement of processes

The aim of our company is to design a fully customised, simple and effective system that serves as a true “tool” for improvement.

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