Our kick-off webinar will introduce you to Platomics, our IVDReady Program, our partners, and IVD Assistant, our platform for compliance.
The first thing your lab needs is a strategy for documenting workflows, whether you’ve got 50 or 250 in-house tests. This webinar will outline several possible approaches.
The next step is formulating the intended purpose for your in-house tests. From here this webinar will also cover documenting qualification as a medical device and risk classification under IVDR.
This webinar will outline Platomics’ regulatory knowledge base that supports labs in understanding what exactly the IVDR requires of them.
Here we’ll show how our Workflow Studio quickly allows your lab to create compliant workflows by integrating manufacturers’ components plus the required documentation from the manufacturer.
Lernen Sie unsere Herstellerpartner kennen und erfahren Sie mehr über die Best-Practice-Workflows, die wir gemeinsam mit diesen auf unserer Plattform entwickeln.
GSPRs sind anspruchsvoll, und genau darin liegt die Schönheit etablierter Standards: Sie sind state-of-the-art und können als solche zuverlässig die GSPRs erfüllen. Finden Sie heraus, was Ihr Labor tun muss und wie Sie es am besten angehen.
Um die Anforderungen zu erfüllen und die Sicherheit und Zuverlässigkeit für Patienten zu gewährleisten, müssen Labore über ein solides Risikomanagementverfahren verfügen. Dieses Webinar bietet Orientierung.
We’ll explain how to fulfill both IVDR and ISO 15189 requirements regarding verification and validation, and how there is no “one size fits all” on this issue.
We’ll take you through various aspects of product excellence required by IVDR, from instructions for use to labeling, SOPs and documenting the design and manufacturing of your in-house tests and components.
Perhaps the most daunting aspect of the IVDR for labs are the new requirements for clinical use surveillance. We’ll explain what active vigilance throughout the life cycle of your in-house tests means for your lab.
Our final webinar will offer an outlook on important aspects for remaining IVDR compliant, including what is coming in the final phase of implementation in 2028.
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.
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.
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 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.
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.