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All information in webinar recording are provided “as is” . They do not constitute legal advice, regulatory consulting, or a substitute for any required formal training. The content reflects Platomics’ understanding of the topic at the time of presentation, and we therefore cannot guarantee its accuracy or completeness. Please seek further advice in case of questions.
February 19, 2026
IN-HOUSE IVDS IN THE LIGHT OF THE IVDR PROPOSAL
In December of last year, the European Commission published the long-awaited proposal to amend the IVDR.
But what does the proposal actually change? What is realistic to expect – and what is not? And most importantly: what could this mean in practice for laboratories that develop and use in-house tests?
In this expert discussion with Erik Vollebregt (AXON Lawyers), we will take an in-depth look at the proposal.
December 9, 2025
ISO15189 Passed – IVDR Failed? The In-House Device Dilemma!
In this webinar, one of the most persistent misconceptions in diagnostics is dealt with: the belief that ISO 15189 accreditation alone makes a laboratory compliant for in-house devices under the IVDR.
We’ll break down the overlap, expose the gaps, and show what Article 5(5) really expects from diagnostic laboratories. Whether your lab builds, modifies, or adapts its own tests, this session will help you understand the In-House IVD trap and how to avoid it with structure, transparency, and smart digital support.
November 4, 2025
Evolution of risk management in the clinical laboratory: from regulatory compliance to true patient care
Explore the evolution of risk management in the clinical laboratory and reveal how structured processes, ethics, and digital tools can transform compliance into care.
We’ll explore how labs can strengthen their risk management frameworks by addressing common bottlenecks in compliance and data integrity. Ideal for lab managers, compliance officers, quality assurance professionals, and researchers who want to streamline operations while staying compliant.
September 17, 2025
IVDR Scenarios Webinar
The IVDR has fundamentally changed the regulatory landscape for diagnostic laboratories. Yet many labs still struggle with one critical question: When does routine practice turn into an In-House IVD under Article 5.5?
This webinar provides practical clarity by walking through real-life scenarios that labs face every day — and explaining exactly where the regulatory line is drawn. We break down five common operational situations and assess their regulatory implications under the IVDR.
Webinarie en français
Ratatouille reglementaire au labo
ISO 15189 is just one ingredient in the complex recipe for IVDR compliance. Laboratories with in-house devices (In House-IVD/LDT) need a tasty mix of overlapping regulatory ingredients all coming together in the same pot. The result may look messy, but there’s a practical method behind it.
ISO 15189 is just one ingredient in the complex recipe for IVDR compliance. Laboratories with in-house devices (In House-IVD/LDT) need a tasty mix of overlapping regulatory ingredients all coming together in the same pot. The result may look messy, but there’s a practical method behind it.
Our French language webinar on IVDR, ISO 15189 and other standards relevant to achieving compliance.
Watch the recoding:
We also offer customized solution packages, including for example support in upgrading to the latest edition ISO 15189: 2022.
Contact us for more information or if your lab has any special requests.
Watch the IVDReady webinars to get started on documenting your in-house tests
Webinar kick-off
IVDReady your lab for compliance by May 2024
Jun 28, 2023
IVDReady Webinar 1
Let’s talk strategy
Jul 10, 2023
IVDReady Webinar 2
Give it a purpose
Jul 28, 2023
IVDReady Webinar 3
Perplexity is the beginning of knowledge
Sep 5, 2023
IVDReady Webinar 4
Gate opening: Introducing the Workflow Studio
Oct 18, 2023
IVDReady Webinar 5
GSPRs are challenging, standards are beautiful
Feb 1, 2024
IVDReady Webinar 6
An ounce of validation
Mar 19, 2024
IVDReady Webinar 7
The real risk is not managing risk
May 7, 2024
For manufacturers
RUOs under IVDR: The benefits of a multi-stakeholder platform
Mar 19, 2024
For Manufacturers
IVDReady your labs for continuous business success
Jul 25, 2023
Even more webinars
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