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.

Jan 30, 2024
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. 

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. 

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.

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.

Innovation to patient, faster

October 5, 2023
Want to know why that’s our credo
as we build an IVDR compliance platform
for labs and manufacturers?

Dig into this top-read Genomeweb story that sets the current regulatory scene for EU labs and global manufacturers under IVDR. (Spoiler alert: Platomics receives mention by the end!) 


While the good intentions of the IVDR are clear to most, many fear that the complex regulatory work required of diagnostic labs, IVD manufacturers and the few notified bodies so far available to certify products under the IVDR will hamper innovation and the availability of tests for patients.  

And indeed, this article quotes both labs and manufacturers that are already feeling the pain one year into fulfilling the first set of requirements, including the General Safety and Performance Requirements or GSPRs. 

Labs are weighed down with the paperwork of risk assessment for their in-house tests, for example, or confronting the fact that they are no longer permitted to use “home-brewed” bioinformatics pipelines developed by another lab and “transferred” to theirs. 

They are also starting to see some of the products used in their workflows disappear because smaller manufacturers are not willing or able to keep up with the new regulations for the EU market. 

It remains to be seen how far such examples of stumbling blocks will continue to mount. What is clear, however, is that the IVDR is here to stay. 

And as precision medicine continues to progress, the trend toward tighter regulation of IVDs is now also gaining momentum in the US, with the FDA gearing up to secure oversight of lab-developed genetic tests in a similar fashion. 

see NYTimes