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.

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.

Nov 2023
5. 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. 

Januar 2024
6. 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. 

Feb 2024
7. 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
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.

April 2024
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.

May 2024
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.

IVDReady by
May 2024 with

Jun 20, 2023 14:00 CEST Online
Our kick-off webinar introduces
IVDReady, a free one-year program
that guides labs to full IVDR compliance

Our kick-off webinar introduces IVDReady, a free one-year program that guides labs to
full compliance for the next round of IVDR requirements pending on May 26, 2024.

This unique program offers a structured path to IVDR fulfillment via monthly webinars
and other activities that support your lab step by step through the requirements
for in-house tests.

Speakers include Platomics in-house regulatory expert Andreas Oberleitner and our guest Dr. Sonja Neuhofen, an expert on IVDR with a focus on in-house diagnostic tests and in vitro diagnostic medical devices.

This webinar includes:

  • an introduction to Platomics and our IVDReady program
  • an overview of what IVDR means for labs
  • an introduction to our program partners
  • a demonstration of PlatoX® IVD Assistant*, our platform for compliance

*cost-free for health institutions for creating IVDR technical documentation for in-house tests


Dr. Sonja Neuhofen

Dr. Sonja Neuhofen has been a freelance trainer in medical device law since 2016. Her specialization is on the IVDR with a particular focus on in-house devices, technical documentation and performance evaluation. Previously she gained 15 years of experience in the area of Regulatory Affairs and Quality Management working with various in vitro device manufacturers.