May 18, 2022

Ask the Writers

Ask the Writers: A Comparison of Critical Elements of the Scientific Validity Report vs. the CER State-of-the-Art and Best Practice Writing Strategies

In this highly interactive question-and-answer session, Criterion Edge experts Laurie Mitchell, President, and Dr. Sarah Chavez, Director of IVD and Scientific Writing Services, will outline the must-have elements for two very similar regulatory reports: the State-of-the-Art section of an EU MDR-compliant Clinical Evaluation Report (CER) and the EU IVDR Scientific Validity Report (SVR).

Participants will understand the required and critical content that is common to both documents and learn best-practice writing strategies to support successful completion of these challenging projects. Come with your questions ready to get feedback from our experts!

Please submit your questions ahead of time while registering for this session so we have ample time to answer them thoughtfully. Also, please be aware that answers will be limited to 3 minutes per question.

This forum will answer questions on a first come first serve basis, so please submit all your questions when you register for this event.

Who is this forum for?

Those regulatory, quality and clinical leaders and teams who are tasked with the development, writing, review, or approval of Clinical Evaluation Reports for MDR submissions or Scientific Validity Reports for IVDR submissions. Anyone interested in learning more about the requirements for these reports is also welcome to attend.

Click here to watch the recording of this session.

Why is it important to establish state of the art during the clinical evaluation?

The large number of mentions of state of the art throughout MEDDEV 2.7/1 rev 4 provide not only a comprehensive description of the importance, purpose, and role of establishing the state of the art, but also inform on how to incorporate this analysis into the clinical evaluation. The image below summarizes several core roles of this analysis.

Establishing and describing state of the art is not an isolated task, but is central to the entire clinical evaluation. Defining the current, accepted best treatment options, and describing the risks and benefits of these options, provides essential information for multiple aspects of the clinical evaluation. Thus, establishing state of the art yields information that is essential for determining if the safety and performance of a device is compatible with current standards (in comparison to available treatment options). In other words, state of the art establishes a reference standard that is used throughout the clinical evaluation.

If you want to find out more about State of the Art according in MEDDEV 2.7/1 rev 4, you can download our full whitepaper.

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April 20, 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 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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February 2, 2022

How to Establish the State-of-the-Art Within the Scientific Validity Report

How to Establish the State-of-the-Art Within the Scientific Validity Report

In this presentation, Criterion Edge’s Principal Medical Writer, Dr. Sarah Chavez, will present focused strategies on building an IVDR-aligned State-of-the-Art (SOA) section within the Scientific Validity Report (SVR). She will also talk about the critical role of the SVR as it relates to the overall performance evaluation process. In addition, you will learn how to assess your SVR project for unanticipated roadblocks and delays. Finally, you’ll see how indecision or incomplete supporting documents can negatively impact SOA (and therefore, SVR) quality and timelines. 

Key Takeaways: 

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

Who should watch the recording?

Those Regulatory, Quality and Clinical leaders, regulatory writers, and teams who are develop, write, review, or approve of Performance Evaluation Reports for EU IVDR submission. Anyone interested in learning more about IVDR requirements for PERs is encouraged to attend as well.

Click here to watch the recording of this webinar.

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

With the implementation of IVDR requirements, IVD manufacturers have been challenged to align their internal processes and systems to comply with these rigorous regulations. Companies realize the need to review published literature for device-specific clinical data to establish the state of the art (scientific validity) and clinical performance of their products, however many manufacturers may not be familiar with or have the capability to perform rigorous, IVDR-compliant systematic literature reviews (SLR), screening, selection and data extraction.

In this practical presentation, Criterion Edge breaks down the steps of the SLR process and takes a wholistic approach to conducting an IVDR-compliant SLR. Using case studies, the presentation illustrates the effective use of SLR-derived data to develop the Scientific Validity Report (SVR) and the Clinical Performance Report (CPR). Watch this webinar.

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November 2, 2021

[FREE WHITE PAPER] Practical Guide: Conducting Systematic Literature Reviews in Support of IVDR Readiness

Overview

This white paper is a companion piece to our popular webinar where we break down the steps of the systematic literature review (SLR) process and take a wholistic approach to conducting an In Vitro Diagnostic Regulation (IVDR)-compliant SLR.

Leveraging published data can help meet global regulatory expectations, fill knowledge gaps, and inform internal decision-making. This applies to IVDR and Medical Device Regulation 2017/745 (MDR) requirements, but for the sake of providing an example, we focus on IVDR here. A methodologically-sound SLR can leverage published data for critical IVDR-required reports (e.g., the Scientific Validity Report, clinical performance). Remember, an SLR is far more than an internet search. It is a clear and robust plan for the identification, retrieval, selection, appraisal, and weighting of published data. SLR has long been the “gold standard” process for evidence-based research, especially in the academic and professional arenas. In today’s regulatory landscape where rigorous methodological SLR principles are now being mandated, adopting a transparent and reproducible process for literature reviews is essential. Every methodologically-sound SLR has 5 clearly defined steps…

Download the rest of this white paper 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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