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.

2024
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. 

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.

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.

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.

Greetings to
the unsung
heroes of the
IVDR!

May 26, 2023
Platomics is declaring May 26 IVDR Day –
but not only to highlight the date for
successive IVDR implementation deadlines.
We see May 26 as a day to celebrate the
brave RA and QM managers who have the
daunting task of realizing IVDR in the lab!

There is no doubt about the mantra that the IVDR was enacted to ensure that diagnostic tests are
safe and effective for patients, but the naked reality is that most labs still lack the resources and specialized
knowledge that are vital to seeing IVDR through.
 

As a manufacturer of IVD medical device software, Platomics early on faced the intricacies of IVDR and was able
to invest heavily in RA a few years ago. 
 

One of the fruits of our efforts is now going live: PlatoX® IVD Assistant, a compliance platform for labs and manufacturers. 

But we also recognized that more was needed to support labs in getting started. So we have developed IVDReady, a free one-year program designed to share with labs the expertise we have accumulated.  

Knowing that the road to compliance can be long and hard – a real “slog” –  we have also created this IVDR Slog Blog to lighten your load and hopefully your spirits as well! Here you will find news and tips, etc, from our regulatory experts. 

Join us and get ready to celebrate next year’s May 26 IVDR Day with your very own set of safe, effective and compliant in-house diagnostic tests. 

Greetings to
the unsung
heroes of the
IVDR!

May 26, 2023
Platomics is declaring May 26 IVDR Day –
but not only to highlight the date for
successive IVDR implementation deadlines.
We see May 26 as a day to celebrate the
brave RA and QM managers who have the
daunting task of realizing IVDR in the lab!

There is no doubt about the mantra that the IVDR was enacted to ensure that diagnostic tests are
safe and effective for patients, but the naked reality is that most labs still lack the resources and specialized
knowledge that are vital to seeing IVDR through.
 

As a manufacturer of IVD medical device software, Platomics early on faced the intricacies of IVDR and was able
to invest heavily in RA a few years ago. 
 

One of the fruits of our efforts is now going live: PlatoX® IVD Assistant, a compliance platform for labs and manufacturers. 

But we also recognized that more was needed to support labs in getting started. So we have developed IVDReady, a free one-year program designed to share with labs the expertise we have accumulated.  

Knowing that the road to compliance can be long and hard – a real “slog” –  we have also created this IVDR Slog Blog to lighten your load and hopefully your spirits as well! Here you will find news and tips, etc, from our regulatory experts. 

Join us and get ready to celebrate next year’s May 26 IVDR Day with your very own set of safe, effective and compliant in-house diagnostic tests.