Accelerate IVDR compliance with PlatoX
PlatoX® is a secure, scalable, global platform that connects IVD manufacturers, laboratories and consultants to facilitate 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 digitally links stakeholders to ease bottlenecks and expedite 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.
Team Platomics
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, bio-informaticians, software engineers and medical experts committed to advancing public health by bringing safe and effective innovations to patients faster. 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.
Our standards
Platomics’ Quality Management System is certified by mdc according to EN ISO 13485:2016 (AC:2018 + A11:2021).
