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.

6. Juli 2023
1. Let’s talk strategy

Das erste, was Ihr Labor braucht, ist eine Strategie für die Dokumentation von Workflows, egal ob Sie 50 oder 250 interne Tests haben. In diesem Webinar werden mehrere mögliche Ansätze vorgestellt.

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.

Oct 12, 2023
4. Gate Opening: Introducing the Workflow Studio

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.

Jan 30, 2024
5. GSPRs are challenging, standards are beautiful

GSPRs are challenging, and therein lies the beauty of established standards: they are state-of-the-art and as such can reliably fulfill the GSPRs. Find out what your lab needs to do and how best to get it done. 

Mar 5, 2024
6. 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.

7. The real risk is not managing risk

Labs will need to have a robust risk management process in place to meet the requirements and ensure safety and reliability for patients. This webinar will provide orientation. 

8. 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.

9. 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.

10. 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.

We offer a clear path
to IVDR conformity
for your in-house tests.

June 23, 2023
Andreas Oberleitner,
Platomics’ regulatory expert,
on the benefits of the
IVDReady Program

Our platform for automating the generation of documentation and other regulatory processes under IVDR offers diagnostic labs increased efficiency, improved collaboration, enhanced traceability, and streamlined regulatory compliance.

It supports the transition to a more efficient and transparent regulatory environment for in vitro diagnostics, ultimately contributing to patient safety and the availability of high-quality diagnostic testing.

Meeting IVDR requirements for in-house diagnostic testing is a legal requirement and a major challenge for many laboratories. There is a lack of time, human and financial resources, and knowledge around this topic.
Our tailored IVDReady program and IVD Assistant platform provide support on several levels. We offer insight into the regulatory requirements as well as solution strategies, compliant templates for documentation, and efficient content creation via wizards.

See our IVDReady kickoff webinar to learn more about the benefits of our 12-month program that guides labs to IVDR compliance for their in-house tests:

IVDReady by May 2024 with Platomics
Available soon online in German and English

Speakers included Andreas Oberleitner and our guest Dr. Sonja Neuhofen, an IVDR expert with 23 years of experience advising labs and manufacturers on medical device law.