Our Quality System

Compliance to quality standards and device reliability are our main focus

Quality and Safety are Dima Italia’s top priority. Our Quality Management System, certified by UNI CEI EN ISO 13485-2016, guarantees compliance to quality standards and ensures the reliability of our devices. The quality procedures are constantly applied in every phase of the production line and controlled by the dedicated Quality department.

In particular, Dima Italia aims at:

  • Optimizing human resources within the firm by a better division of internal responsibilities
  • Standardizing the various areas management to give a quick and efficient response to customer and market requests
  • Assuring a constant revision of all technical products documentation so that the company may comply with new regulations
  • Increasing the competitiveness of the products by controlling their impact on the market and constantly implementing their technical qualities
  • Improving time and costs estimation when setting up a new project, making the most out of our previous experiences
  • Ensuring the application of the longstanding experience in the respiratory field in each product cycle
  • Assuring a good Technical Assistance with qualified staff

All Dima Italia products comply with the specific European Safety rules and are certified according to the 93/42/CEE directive and with the approval of the Notified Body ICIM S.p.A.

During the design project, high quality components are used thanks to a careful selection of components and their correspondent supplier. Each production lot is submitted to various controls and inspections including acceptance tests of the used components, final and intermediate inspections: working controls, acceptance tests and quality inspections.

Furthermore, several products obtained the US FDA and Taiwanese and Japanese certification.