We are going to make genetic testing available to everyone and to change the way genetic data is managed and analysed, through game-changing software solutions for personalized medicine.
A genetic test will be as easy and accessible as a simple blood test.
PlatoX® IVD Assistant launch in March 2023 - Pre-register now
Innovation to patient, faster
Platomics enables in vitro diagnostic manufacturers and laboratories to bring safe and effective innovations to market with unparalleled speed and efficiency.
Our global platform for generating and marketing compliant IVD products is equipped with intelligent regulatory automation that allows our clients to seamlessly overcome regulatory challenges throughout the life cycle of their products.
Breeze through the IVDR with PlatoX
PlatoX is a secure, scalable, global platform that connects IVD manufacturers, laboratories and consultants to accelerate compliance – enabling IVD business to run smoothly across regulatory and data security borders.
We are automating regulatory processes across the entire product and market life cycle, saving time, costs and resources for manufacturers and labs.
Our platform connects with regulatory consultants and offers bridges to EU Notified Bodies in order to avoid bottlenecks and ease compliance across geographical regions.
A new regulatory landscape
The EU-IVDR is now fully in force, creating a ripple effect that leaves no stakeholder unaffected. The spirit of the IVDR is to ensure maximum patient benefit from innovations in diagnostic tests, yet the challenges it creates for EU labs and global manufacturers threaten to limit the accessibility of tests for patients who need them.
PlatoX supports manufacturers and labs in quickly generating the new documentation necessary to keep devices compliant and on the market, as well as to make new tests available for patients faster. Our platform accelerates IVDR certification through automation and a digital ecosystem connecting all stakeholders involved in the certification process.
Our standards
Platomics Quality Management is certified by mdc according to ISO 13485:2016 for the design and development, manufacture, operation and distribution of analyzing software for genetic testing.
Nr.: D4005700004
Our company and the team
Platomics is a Vienna-based company specialized in regulatory automation and the design, development, manufacture and operation of digital in vitro diagnostic medical devices.
We are a vibrant team of regulatory experts, bioinformaticians, software engineers and medical experts committed to advancing public health by bringing safe and effective innovations to patients faster.
PLATOMICS GMBH
Office address:
Jakov-Lind-Strasse 15/Floor 2/Top 3
1020 Vienna
Phone +43 660 7154 402