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 over the entire 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
FOR THE ENTIRE IN-VITRO DIAGNOSTIC MARKET
The EU-IVDR will change the way in-vitro diagnostic tests are done in Europe and for European citizens. No stakeholder will be left unaffected. Platomics anticipates these changes and supports its customers to meet the needs for the whole life-cycle of a genetic test. Starting from a regulatory or bioinformatic gap analysis, through the design of customized kits, the validation of kits and software, the creation of regulatory compliant document and to the compliant analysis of genetic data.
Platomics Quality Management is certified by mdc according to
ISO 13485:2016 for design and development, manufacture, operation and distribution of analyzing software for genetic testing (PlatoX); headquarters; design and development, manufacture, operation and distribution of analyzing software for genetic testing (PlatoX); design and development, manufacture, operation and distribution of analyzing software for genetic testing (PlatoX).
OUR COMPANY AND THE TEAM
Platomics is a spin-off of the AIT - the Austrian Institute of Technology. The company was founded to enable innovative analysis software for genetic data in clinical diagnosis. We are a vibrant team of medical experts, geneticists, bioinformaticians, software engineers and regulatory experts. We apply the most advanced computing technologies to enable big data processing and analysis in healthcare.