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.


Here you will find various resources
for all your compliance endeavors.

Strategy Wizard Sneak Preview 

Not sure how to begin IVDR documentation of your in-house tests?  

What you need is a strategy. This interactive wizard will get you started with basic IVDR
know-how and then lead you straight to the right strategy for your lab.  

IVDReady and PlatoX® IVD Assistant

The purpose of the IVDReady webinar series below is to guide labs as they progress through IVDR documentation for their in-house tests.  

Each webinar informs you about the next steps and demonstrates how to get them done efficiently on our platform.  

To begin IVDR technical documentation for your lab’s in-house tests parallel to the webinar series, register here for access to PlatoX®IVD Assistant.  

Registration and use of IVD Assistant will remain perpetually free of charge for diagnostic labs for the purpose of IVDR documentation of in-house tests.  

IVDReady Webinar Series

Watch the webinars and get started
on documenting your in-house tests

We provide the structure, the know-how and the tools for getting IVDR compliance done – free of charge for health institutions.