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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October 21, 2021

[FREE WHITE PAPER] How to Establish the State-of-the-Art Within the Scientific Validity Report

Overview

This white paper is a companion piece to our popular webinar where we cover the state of the art process and how it fits into the In Vitro Diagnostic Regulation (IVDR).

The SVR is a critical component of the IVDR in that it establishes the association of the analyte with the clinical condition or physiological state. Regulators expect manufacturers to demonstrate a thorough clinical evaluation of the IVD in the context of what is generally acknowledged as SOA. To establish that your IVD reflects the current best-practice, you must be able to show how it fits into the entire scientific landscape and explain the circumstances and diagnostic scenarios by which the IVD can be considered SOA. Here, we discuss the critical role of the SVR in establishing SOA as it relates to the overall performance evaluation process.

Solution

The SVR is your chance to …

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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October 20, 2021

[Ask the Expert] Performance Evaluation Report

performance evaluation report

This session’s topic: The Performance Evaluation Report (PER)

With the implementation of IVDR requirements, IVD manufacturers have been challenged to align their internal processes and systems to comply with these rigorous regulations. What challenges are you or your team currently facing? Which areas do you need performance evaluation report guidance?

During this 45-minute Q&A session, our President Laurie Mitchell and Principal Medical Writer Dr. Sarah Chavez answered questions on the role of the State-of-the-Art section within the PER, whether using a PER template is right for you including what the notified body expects to see, and the methodology and strategy for PER, PEP, and PMPF plans.

Who should watch this webinar?

Regulatory, Quality and Clinical leaders and teams who develop, write, review or approve Performance Evaluation Reports for EU IVDR submission.

Watch the recording!

What You Need to Be Compliant

Watch our recent webinar for more performance evaluation report guidance. We provide an overview of the State of the Art section, and explain how it fits into the overall process of writing a successful, IVDR-compliant PER. Additionally, we discuss the importance of readiness assessments and gap analyses. Then we help you identify critical resources, feeder documents, and expertise needed to consider your IVD “state-of-the-art.” Ultimately, knowing what the Notified Body expects to see will help you avoid project delays and discover efficiencies in the SOA development process.

Ultimately, the In Vitro Diagnostic Device Regulation 2017/746 is making sweeping changes to the EU regulatory requirements for IVD devices. Read our blog post for more on this topic. In it, we introduce some of the major requirements and list some of the important considerations for IVDR 2017/746 compliance.

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October 6, 2021

[Ask the Expert] Performance Evaluation Report

performance evaluation report

This session’s topic: The Performance Evaluation Report (PER)

With the implementation of IVDR requirements, IVD manufacturers have been challenged to align their internal processes and systems to comply with these rigorous regulations. What challenges are you or your team currently facing? Which areas do you need performance evaluation report guidance?

During this 45-minute Q&A session, our President Laurie Mitchell and Principal Medical Writer Dr. Sarah Chavez answered questions on the biggest pitfalls to look out for when writing a PER. In addition, they discuss how to align your internal processes and systems to comply with rigorous IVDR regulations and what technical documents are required for the PER, PEP, and PMPF.

Who should watch this webinar?

Regulatory, Quality and Clinical leaders and teams who develop, write, review or approve Performance Evaluation Reports for EU IVDR submission.

Watch the recording!

What You Need to Be Compliant

Watch our recent webinar for more performance evaluation report guidance. We provide an overview of the State of the Art section, and explain how it fits into the overall process of writing a successful, IVDR-compliant PER. Additionally, we discuss the importance of readiness assessments and gap analyses. Then we help you identify critical resources, feeder documents, and expertise needed to consider your IVD “state-of-the-art.” Ultimately, knowing what the Notified Body expects to see will help you avoid project delays and discover efficiencies in the SOA development process.

Ultimately, the In Vitro Diagnostic Device Regulation 2017/746 is making sweeping changes to the EU regulatory requirements for IVD devices. Read our blog post for more on this topic. In it, we introduce some of the major requirements and list some of the important considerations for IVDR 2017/746 compliance.

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September 15, 2021

How to Establish the Competitive Landscape Within the Scientific Validity Report

how to establish the competitive landscape within the scientific validity report with the state of the art search

In this practical presentation, Dr. Sarah Chavez, presents a detailed outline of the 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 watch the recording?

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.

Watch the recording!

Building a Solid Foundation for your PER to Support IVDR Readiness

Watch our recent webinar where we present an overview of the State of the Art section. Namely, we explain how it fits into the overall process of writing a successful, IVDR-compliant Performance Evaluation Report (PER). In addition, a complete readiness assessment and gap analysis will help you identify critical resources, feeder documents, and expertise needed establish your IVD as “state-of-the-art.” Ultimately, knowing what the Notified Body expects to see will help you avoid project delays and discover efficiencies in the SOA development process.

You will learn:

  • The importance of planning and preparation before you even begin to write the SOA
  • The complete outline of the SOA literature review and assessment process to understand “documentation” needs and what the Notified Body may be expecting to see as part of the Scientific Validity Report (SVR)
  • The potential impact  of incorrect/incomplete documents or processes

To watch the free webinar recording, State of the Art: Building a Solid Foundation for your PER to Support IVDR Readiness, click here.

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