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.

IVDReady your
lab for
compliance
by May 2024

Our unique program takes your lab
on a 12-month guided trek to reach
IVDR compliance for your in-house tests.

IVDReady is a free one-year program that navigates labs to full compliance for the next phase
of IVDR requirements pending on May 26, 2024. We offer a structured path forward with
monthly webinars and cost-free use of our compliance tool, PlatoX® IVD Assistant.*

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



By now, all labs are to have fulfilled the General Safety and Performance Requirements.
And by May 2024, a vastly more comprehensive set of requirements must be met for each
in-house diagnostic test.

The IVDReady Program offers labs:

  • Cost-free use of PlatoX® IVD Assistant for creating the entire set of IVDR technical
    documentation for in-house tests, including wizards, templates and rules-based automation
    for generating content.
  • Monthly webinars and regular activities that walk you through the strategy and
    know-how needed for meeting the requirements, from standards to intended purpose
    and clinical use surveillance.
  • Guidance and information from our in-house regulatory experts plus guest speakers.
  • Access to the required IVDR documentation from our manufacturer partners for
    common lab components including sequencers, reagents, reference materials, etc.

Benefits for labs

Save time and effort

Our platform’s wizards, templates, automation and knowledge-base make it quicker and easier to document your in-house tests.

Get guidance

The program offers expert support for the full range of IVDR documentation, with monthly activities to keep you on schedule for bringing your lab to compliance by May 2024.

Reduce costs

The IVDReady Program and use of IVD Assistant for IVDR technical documentation of in-house tests are free of charge for health institutions including diagnostic labs.

Data security

Our data for IVD Assistant is stored in and will remain in an ISO 27001-certified external data center in Vienna. We respect the requirements of the GDPR and do not transfer any data to third countries lacking the level of protection required by the GDPR. 

Certificate

Receive a certificate of completion from Platomics at the end of the program.

Image

IVDReady webinar series

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.