Biomaneo obtains ISO 13485:2016 certification and strengthens its quality team

A key step for the marketing of its In Vitro Diagnostic Devices (IVDD) and in the transition to the new 2017/746 regulation.

Obtaining ISO 13485 certification is the result of a great teamwork that began more than two years ago. It reflects the management's desire to work in an environment of continuous improvement and to offer its customers quality, reliable and high-performance products.

Customer satisfaction and product safety are at the heart of our quality management system, whose quality policy is based on four main areas:

  • Responding to Public Health needs and issues

Biomaneo offers technological innovations adapted to large-scale screening of various pathologies while controlling costs

  • Improving performance and quality in our practices

Biomaneo does not hesitate to strengthen its expertise through training, the hiring of new skills and the acquisition of the latest generation tools

  • Marketing quality products and services and meeting customer requirements

Biomaneo always listens to its customers and ensures the traceability of its products

  • Commitment to meeting legal, normative and regulatory requirements

Biomaneo guarantees the compliance of its products with current regulations by monitoring its processes

The certification covers the design, development, manufacturing, marketing (including installation, maintenance and training) of our IVDMD products (kits and software) for mass spectrometry screening.

To reinforce and maintain the efficiency of our quality management system, we are pleased to hire Mrs Cassandre Devos, Quality and Regulatory Affairs Engineer, who has just finished her work-study contract, as a recent graduate of ISIFC.