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.

What’s a Workflow Studio for, anyway?

November 9, 2023
Our Workflow Studio has gone live
and we’ve opened the gates!

But wait a minute, the IVDR says that labs must document their in-house tests.

So one question we often hear is:

Why document entire workflows? 

Let’s start at the beginning:

What does the IVDR demand of manufacturers and labs? 

Manufacturers must fulfill stringent new requirements to CE-mark their products. Famously, this fact—combined with the small number of notified bodies accredited for IVDR certification thus far—has created a bottle neck in (re)certifying over 30,000 products. 

And labs must now show that they fulfill some of the same requirements as manufacturers for all in-house-developed IVD tests. The logic here: If a lab alters any aspect of a product’s intended purpose or use—as defined by the manufacturer—they become the de facto manufacturer of the test they offer. If you modify it, you’ve manufactured it. 

So why document workflows? 

Some lab-developed tests are more complex and involve many components—not all currently CE-marked (in part because of the bottleneck) nor used exactly according to the manufacturer’s intended scope. One clear example here: the rapidly developing realm of genetic testing for rare diseases and oncology. 

And some combinations of components are used in several different tests, for example PCR, and are thus best documented together and embedded within the documentation for more complex workflows. 

So it is often easier for a lab to group the components into a single “system” of devices. Then the lab can describe the individual steps they follow—some perhaps out of the intended scope—and document this system as a workflow that can be validated as a whole. Most of the labs we work with are gravitating toward this strategy. 

What is the “gate opening” and what does it do for labs? 

Let’s say your lab has decided on the strategy to group and start documenting a workflow. Why use the Workflow Studio? 

Because automation is so much faster than collecting and filling in component information manually! Our tool establishes a connection between manufacturers and labs to ensure you automatically get up-to-date information about the components when you build your workflow. This information then reappears wherever you need it in your documentation. 

In the Workflow Studio, just select the components you use from the growing product list on our platform to put together a workflow. The result: the product name, manufacturer information, product metadata, regulatory status and a description are integrated into the workflow documentation and into each set of subsequent documentation where needed. 

If you do not find in our product list a particular component needed for one of your workflows, either fill it in manually or create a placeholder and then use the request form that notifies the manufacturer of your product request. 

The big picture 

We at Platomics are in awe of the incredible pace of innovation as precision medicine evolves. And we believe in ensuring that innovative diagnostics are available, safe and effective. This is why we are building a multi-stakeholder compliance platform: to simplify and speed up the regulatory route—to bring innovation to patients, faster.