IVDReady webinar series
COMING SOON 26/05/2024 4:07 am
Jun 20, 2023
IVDReady by May 2024 with Platomics

Our kick-off webinar will introduce you to Platomics, our IVDReady Program, our partners, and IVD Assistant, our platform for compliance.

Jul 6, 2023
1. Let’s talk strategy

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.  

Jul 25, 2023
2. Give it a purpose

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.

Aug 29, 2023
3. Perplexity is the beginning of knowledge

This webinar will outline Platomics’ regulatory knowledge base that supports labs in understanding what exactly the IVDR requires of them.

Sep 2023
4. Workflow by design

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.

Okt 2023
5. Meet the manufacturers

Lernen Sie unsere Herstellerpartner kennen und erfahren Sie mehr über die Best-Practice-Workflows, die wir gemeinsam mit diesen auf unserer Plattform entwickeln.

Nov 2023
6. Standards are beautiful

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.

Januar 2024
7. The real risk is not managing risk

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.

Feb 2024
8. An ounce of validation

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.

Mar 2024
9. Product excellence: Everything, everywhere, all at once

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.

April 2024
10.  Vigilance: The shield, sword and light

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.

May 2024
IVDReady at last

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.

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 company and the team

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.

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.