The medical industry

Solutions made in accordance with the ISO 13485 standard
Medical industry
Project development processes adapted to the medical industry
Qualimatest is ISO13485 certified to carry out projects and validations according to the standards of the medical industry.

In order to respond even more effectively to the expectations of our customers and to adapt to current regulations, Qualimatest has continued to improve its processes and adapted its quality management to medical requirements.

The medical market today represents more than 10% of Qualimatest's activity:

Qualimatest demonstrates, through its ISO 13485 certification, recognized expertise in the development and implementation of quality control systems for the medical sector. The requirements of ISO 13485 apply to companies that design control systems for the use of medical devices.

Throughout the value chain, Qualimatest products are designed, developed and manufactured with the goal of being safer and more efficient. Particular rigor is focused on the traceability and risk analysis of vision systems for the medical sector. The risk analysis is integrated into the risk management file of the produced object. The formal validation of the GAMP (Good Automated Manufacturing Practice) or other software must be detailed and transmitted.

The strengths of a collaboration with QMT:
  • The ISO 9001 and ISO 13485 certified management system
  • Development of solutions on our hardware and software platform
  • Our projects, based on the V process, is the guarantor of the project's success
  • A medical standard for the DQ / IQ / OQ / PQ qualification
  • An organization to guarantee the maintenance and the durability

 

 
Mastery of work and technologies
A company with a broad know-how

Mastery of multiple disciplines such as micromechanics, electronics, optics, automation and software

Know-how
 
Customized solution
Customized solutions on specifications

Qualimatest designs, develops and industrializes solutions that meet the specifications of its customers

Customized solutions
 
From the Qualimatest standard
Products for quality control

A range of powerful products developed by our team. The Fit For You program allows customization

Products
From SMEs to multinationals in various industries more than 100 customers have trusted Qualimatest
project management and technical know-how
ISO-certified project management to guarantee success

In order to guarantee the success of the projects, our team of Project Managers is in charge of defining the specifications of the solutions as well as the smooth running of the projects. Continuous monitoring during development ensures time and budget

The benefits and strengths of QMT:
  • Writing specifications in collaboration with the client
  • Knowledge of the specificities of the industrial sectors
  • FAT and SAT validations to check functionality
  • V or Agile process to adapt to projects
  • An ISO 9001 and ISO 13485 certified organization
More information