March 1, 2022

How to Establish the Competitive Landscape Within the Scientific Validity Report

In this practical presentation, Dr. Sarah Chavez, will present a detailed outline of the IVDR State of the Art search within the Performance Evaluation Report (PER). Additionally, she will distinguish between the purpose and scope of the state-of-the-art and the Competitor search. For example, the SLR approach, data screening, and data presentation will be addressed.

You will learn:

  • The importance of the SOA SLR for providing background and general information
  • How to establish acceptance criteria with data
  • How to assess the safety and performance of your IVD with a systematic approach to the Competitor SLR process

Who should attend?

Those Regulatory, Quality and Clinical leaders and teams who develop, write, review or approve Performance Evaluation Reports for EU IVDR submission. Also, anyone interested in learning more about the competitive landscape within the Scientific Validity Report should attend.

Click here to watch the webinar recording.

IVDR Essentials: Performance Evaluation Report – Early Planning and Preparation

How can scoping help you identify critical internal documents needed for IVDR readiness? What are the benefits to beginning the process early? There are many moving pieces needed to write a PER, so we have developed strategies to keep you and your team on track and help assess your own level of preparedness. Using our CE Scoping checklist, we will walk through the necessary documents, SOPs, processes, reports, and templates, and explain how each of these fits into the overall process of preparing to write.

This presentation will emphasize the importance of scoping, discuss how to develop a checklist, and illustrate how scoping may help you identify gaps or missing pieces that could lead to delays or challenges in your PER writing process.

Watch the free webinar recording now.

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February 25, 2022

[FEATURED] Notified Body Shortage Remains Pressing as Industry Prepares for Staggered IVDR Rollout

Three months have passed since the European Commission warned about a “grave shortage of notified body capacity,” but the situation is largely unchanged.

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February 16, 2022

[Ask the Expert] Clinical Data for IVD

Clinical Data for IVD: What is it and How Do I Find It?

Do you have questions about how to generate, collect, analyze, or assess clinical data pertaining to your IVD? What are the best practices for conducting literature searches? How do you effectively present your data in your performance evaluation report? Whether you are just beginning your PER preparations or are already in the process of writing, we will provide insights and suggestions to help make the process of data collection, extraction, and presentation more streamlined.

This forum answers question like these and more. Click here to watch the recording.

Who watch this forum?

Those Regulatory, Quality and Clinical leaders and teams who develop, write, review, or approve performance evaluation reports for IVDR submissions.

A Practical Guide: Conducting Systematic Literature Reviews in Support of IVDR Readiness

The implementation of IVDR requirements has challenged IVD manufacturers to align their internal processes and systems with these rigorous regulations. Therefore, companies realize reviewing published literature for device-specific clinical data to establish the state-of-the-art (scientific validity) is imperative. In addition, establishing clinical performance of their products is key. However, many manufacturers may not be familiar with or have the capability to perform rigorous, IVDR-compliant systematic literature reviews (SLR). Finally, screening, selection and data extraction are typically challenges for manufacturers as well.

In this presentation we break down the steps of the SLR process and take a wholistic approach to conducting an IVDR-compliant SLR. Next, using case studies, we illustrate the effective use of SLR-derived data to develop the Scientific Validity Report (SVR) and the Clinical Performance Report (CPR).

Key Takeaways:

  • Review the essential steps for conducting a robust, methodologically-sound systematic literature review
  • Using a typical case study scenario, learn how to effectively search, identify, screen, review and extract critical published clinical data on your subject IVD device to support the development of the Scientific Validity and Clinical Performance Reports.

Watch this webinar recording.

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February 9, 2022

[FREE WEBINAR] How to Establish the State of the Art Within the Scientific Validity Report

Click here to watch the recording of this webinar.

In this practical presentation, Criterion Edge presents focused strategies on building an IVDR-aligned State of the Art (SOA) section within the Scientific Validity Report (SVR). We also talk about the critical role of the SVR as it relates to the overall performance evaluation process.

Key Takeaways:

  • The foundational role of the SOA in the SVR
  • The required components of the SOA such as the safety and performance objectives
  • The importance of a robust systematic literature review (SLR) to support your SOA

Who Should Watch:

Those Regulatory, Quality and Clinical leaders and regulatory writers who are tasked with the development, writing, review, or approval of Scientific Validity Reports for EU IVDR submission, or anyone interested in learning more about the SOA section within the SVR.

Who are the Panelists?

Dr. Sarah Chavez, Principal Medical Writer | Criterion Edge

Sign up for future webinars here.

Criterion Edge has the expertise and resources to do literature reviews for many types of documents. Ready for a free consult?

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January 25, 2022

[FEATURED] Industry Points To Key Outstanding IVDR Issues As EU Council Greenlights Deadline Extensions

The Council of the EU has followed the European Parliament in rubberstamping the European Commission’s proposal for selected IVDR transition deadline extensions, as expected. Industry has expressed relief, but points to other outstanding IVDR issues that also need urgent EU attention.

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[Free Webinar] IVDR Readiness: Creating a Blueprint to Build a Strong PER

Join us on Wednesday, June 7th, 2023 at 11 AM PST, as our regulatory experts discuss the process of writing a PER, with careful attention to the importance of aligning technical documents to create a cohesive, well-organized report.

Spots are limited – click to register for this free webinar.

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