Leuven, Belgium—October 29th , 2019 – miDiagnostics has agreed a partnership with Notified Body, BSI (the Netherlands) to assess and certify the miDiagnostics Quality Systems to ISO 13485 (2016) in preparation for the CE marking and 510(k) clearance of the miDiagnostics range of diagnostic devices.
miDiagnostics is developing a new generation of disposable tests that require only drops of blood and allow detection of cells, proteins, nucleic acids, and/or small molecules.
Its core technology is a novel silicon-based nanofluidic processor that automatically processes the blood sample without the need of pumps or valves.
There is no need for complex and costly instrumentation enabling medical decisions to be taken at the point of need or remote areas with a high level of comfort to both patients and caregivers.
“We are very delighted to announce our readiness for this next key phase of our development. This partnership with BSI brings us one key step nearer to the market,” Ben Chambers, VP Quality and Regulatory Affairs, comments.
miDiagnostics was founded in 2015 as a spin-off from imec (Leuven, Belgium), and a research collaboration with the Johns Hopkins University (Baltimore, USA), America’s first research university and medical school and home of over 30 Nobel Prize laureates.
Following a Series A round of €60 million, led by Alychlo, Pamica and PMV, miDiagnostics was incorporated to further build on the extensive research, and scientific and clinical expertise of these two institutes.
For further information please contact Ben Chambers VP Quality and Regulatory Affairs, miDiagnostics
Gaston Geenslaan 1