MitoFit-Medical device

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MitoFit         NextGen-O2k         K-Regio MitoFit         O2k-Innovation         Houska-Award 2012         K-Regio MitoCom         Bioblast 2012


MitoFit-Medical device

The project MitoFit highlights the benefits of mitochondrial fitness.


MitoFit Workpackages


WP1

The O2k from research instrument to medical device


Abstract

The legal provisions and their impact on the instrument will be collected and evaluated. An action plan will be developed, describing all necessary steps on the way for the O2k to become a medical device. The most effective but also most expensive marketing strategy would be to seek approval as a medical device simultaneously with a CE Mark and FDA clearance for the O2k, since 44% and 24% of our present research instruments are placed in the EU and US, respectively. Regulatory risks need to be considered for the launch of the O2k as a medical device, versus the risk of loosing a market in the EU, US or other countries when audit requirements become more stringent even in the field of mitochondrial research linked to human health and disease.


Progress and next steps

» MitoFit Workshop en.co.tec medical device 2016-02-04
» MitoPedia: O2k hardware
» MitoPedia: DatLab
» MitoPedia: SUIT


Links and references

» Websites CE and FDA approval: FDA: In Vitro Diagnostics
» ISO 17511:2003 In vitro diagnostic medical devices
» ISO 10012:2003 Measurement management systems
» ISO 9001:2015 Quality management systems - requirements
« Back to overview