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.