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.

Perplexity is the
beginning of knowledge

August 29, 2023 14:00 CEST Online
The IVDR is complex.
Our Knowledge Base anticipates your questions
and leads the way to compliance.

IH-IVDs, LDTs, HIs, Competent Authorities… The IVDR has created a whole new set of terminology for labs to navigate. These terms are essential to fulfilling the new requirements. 

Platomics has you covered with an IVDR glossary and other neat gadgets to reduce complexity. 

This webinar outlines the regulatory knowledge base available to you through the IVDReady Program and our compliance platform toolbox, PlatoX IVD Assistant.  

Agenda: 

  • Guest speakers: 
    • Dr. med. Peter Horak, National Center for Tumor Diseases Heidelberg 
    • Mag. iur. Marie Salin, Salin Consulting 
    • Mag. Erich Zeisl, Austrian Standards plus GmbH 
  • An introduction to our Knowledge Base
  • A demonstration of our Risk Classification Wizard to bring you one step further in documenting your in-house tests 

Speakers

Dr. med. Peter Horak

Dr. Horak is a hematologist and oncologist serving as deputy head of the Division of Translational Medical Oncology at the National Center for Tumor Diseases (NCT) Heidelberg. He is currently involved in setting up an Interdisciplinary Laboratory for Precision Medicine with the NCT and the Center for Rare Diseases Heidelberg. 

Mag. iur. Marie Salin

Marie Salin is owner and founder of Salin Consulting and Managing Director of West Medica GmbH. 

Mag. Erich Zeisl

Erich Zeisl is Head of Production at Austrian Standards plus GmbH.