ISO 13485 2016 Certification Acquired For Quality Management System

Fluidda acquired an ISO 13485 2016 certification for its Quality Management System.

We are pleased to announce that Fluidda’s Quality Management System now has an ISO 13485 2016 certificate. We are currently in the middle of the certification process for Broncholab under the MDR scope and will soon obtain a CE certificate for Broncholab.

In March 2020, the US Food and Drug Administration provided market clearance to Fluidda for its Broncholab platform. Broncholab provides several Functional Respiratory Imaging (FRI) parameters to physicians via an online platform to assist in diagnosing and monitoring of respiratory diseases.

The severity of respiratory diseases is often underestimated by conventional lung function tests, such as spirometry. Quantitative HRCT techniques such as FRI provide additional relevant information unavailable via conventional tests. FRI parameters yield accurate regional information which helps to understand what happens locally and increases insights in the nature of the disease. Such information is clinically relevant for diagnosis, follow up and early adjustments to the therapy for individual patients.

More information about broncholab can be found here: