Criterion Edge's resources are constantly being updated to include new downloadbles and webinars to keep you up to date. We share informative white papers and rich, interactive live webinars on industry's best practices, techniques for ensuring that your regulatory documents are compliant, and much more.
Critical Concepts Webinar Medical Device Software: Approaches to Determining Risk Classification, Qualification, and Safety and Performance Outcomes
Understand how to address the clinical evaluation for your medical device software, define the safety and performance outcomes, and other clinical evaluation parameters.
CER Critical Concepts: Effectively Telling the Story of the CER- Focus on S&P Objectives, Acceptance Criteria, Clinical Benefits and Risk-Benefit Analysis
Presented from the point of view of seasoned MDR-compliant CER medical writers, this session takes a practical approach to defining the key foundational concepts of the Clinical Evaluation Report (CER).
Ask the Expert: Understanding Clinical Data Sufficiency and Strategies to Address Limited Clinical and Performance Data
This session covers differences between a well-established technology and a legacy device, the meaning of data sufficiency, the impacts of data and the route to conformity, and Clinical Evaluation Plan best practices.
Demonstration of Sufficient Evidence and Regulatory Strategy Alignment in the Clinical Evaluation Process
In this webinar, we discuss the concept of data sufficiency, give you strategies for addressing limited clinical and performance data, and discuss adjusting the Clinical Evaluation Plan to align with the regulatory strategy.
[Ask the Writers] A Comparison of Critical Elements of the SVR versus the CER State-of-the-Art and Best Practice Writing Strategies
This session answers questions like when the SOA should be established and written, the best approach to take when writing a CER, strategies for legacy, wet, or low risk devices, and more.
[Ask the Expert] Tips On How To Avoid Common Notified Body Review Findings
This session answers questions regarding how to avoid the most common missteps in your own CER or PER, addressing NB feedback to meet critical submission deadlines, improving your writing process for these regulatory documents, and more.
[Ask the Expert] Clinical Data for IVD: What Is It and How Do I Find It?
This session answers questions regarding sources of data, data sufficiency, sample size, demonstrating clinical performance, conducting clinical studies, effective data presentation in the Performance Evaluation Report, IVDR data requirements, and more.
IVD Deep Dive Series Part 1: Safety and Performance Measures and Acceptance Criteria
This session presents strategies for the verification of IVD clinical performance in the PER. Learn how to identify meaningful and measurable performance measures and define acceptance criteria parameters to support the benefit-risk analysis.
IVDR Essentials: Performance Evaluation Report - Early Planning and Preparation
This session presents IVDR essentials including strategies for assessing critical components of your PER for possible misalignment with key IVDR requirements, and how to assess your PER processes and document for possible gaps prior to submission.
How to Establish the State-of-the-Art Within the Scientific Validity Report
From this presentation you will learn 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, and how to assess your SVR project for unanticipated roadblocks and delays.
[Ask the Expert] Safety and Performance Measures and Acceptance Criteria for IVDR
This Q&A session answers questions on how to define safety and performance endpoints, the best methods and practices for identifying the acceptance criteria for your IVD, the difference in processes for new devices versus established devices, and more.
Post-Market Literature Surveillance: Systematic Literature Review and Case Study
In this webinar, you will learn how to deploy systematic literature review in order to augment post market clinical surveillance, and share our best tips on a robust systematic literature review process. A case study illustrates a real world example.
[Ask the Expert] Safety and Performance Measures and Acceptance Criteria
In this Q&A session, we answer questions on how to identify meaningful safety and performance measures including sufficient data collection, acceptance criteria ranges, and how to demonstrate S&P measures are appropriate and clinically relevant.
How to Establish the Competitive Landscape Within the Scientific Validity Report
In this practical presentation, you'll find a detailed outline of the State-of-the-Art search within the PER as well as the distinction between the purpose and scope of the SOA search and the Competitor search, in terms of the SLR approach, data screening, and data presentation.
Clinical Evaluation: Measurable Objectives and Acceptance Criteria to Verify Device Safety and Performance
In this presentation, we present strategies for the verification of device safety and performance. We help you with identifying meaningful safety and performance measures for the clinical evaluation and with defining parameters to determine the acceptability of benefit-risk.
How to Establish the State of the Art Within the Scientific Validity Report
In this presentation, we present focused strategies on building a State of the Art section within the Scientific Validity Report. You will learn the critical role of the SVR within the overall performance evaluation process, required components of the SOA, and the importance of a robust systematic literature review (SLR) to support your SOA.
Hidden Traps That Can Derail Your CER: Answer These Critical Questions Before You Start Writing
Based on our experiences with clients both large and small, our President, Laurie Mitchell, shares some of the biggest issues we have discovered when starting an MDR CER project. Laurie also reveals some of the most successful strategies in addressing these issues, up-front and early.
State of the Art: Building a Solid Foundation for your PER to Support IVDR Readiness
Dr. Sarah Chavez provides an overview of the State of the Art section, explains how it fits into the overall process of writing a successful IVDR-compliant Performance Evaluation Report (PER) in a reasonable time frame, and explains potential impacts of incorrect/incomplete documents or processes.
Leveraging the MDR Experience for IVDR: Tips for Successful Performance Evaluation and PMS/PMPF Processes
Our President Laurie Mitchell is joined by our special guest speaker Caroline Byrd, VP of Regulatory, Quality, and Clinical from Nextern, to discuss their experiences supporting clients through MDR and IVDR requirements, and what you need to know about becoming IVDR-ready.
Effective Corporate Scientific Communication: Strategies to Support your Corporate Narrative and Maximize the Real-World Impact of your Data
In this practical presentation, President Laurie Mitchell will discuss the importance of an effective scientific communication plan and present strategies to ensure your corporate objectives are supported and maximize the real-world impact of your data.
Hidden Traps That Derail PER Preparedness: Lessons Learned from the MDR-Compliant CER Writing Experience
In this practical presentation, Criterion Edge uncovers what we have learned from our experience in writing MDR-compliant CERs, and how urgently applicable some of these key learnings are in preparing a robust Performance Evaluation Report (PER).
A Practical Guide: Conducting Systematic Literature Reviews in Support of IVDR Readiness
In this practical presentation, we break down the steps of the SLR process and take a wholistic approach to conducting an IVDR-compliant SLR. Using case studies, this webinar illustrates the effective use of SLR-derived data to develop the Scientific Validity Report (SVR) and the Clinical Performance Report (CPR).
State of the Art Literature Review for EU MDR Compliance: How To Get It Right
Establishing and defining state of the art for a medical device is no longer an isolated task – it supports the entire Clinical Evaluation Report (CER). Multiple sections of the MEDDEV 2.7/1 rev 4 compliant CER need to be supported by state of the art data, including safety and performance, risk management, and equivalence.
State of the Art: Establishing a Solid Foundation For Your PERs to Encourage IVDR Readiness
In this white paper, we cover the state of the art process and how it fits into the In Vitro Diagnostic Regulation (IVDR). Use the task list to guide your organization's SOA in the context of the PER and IVDR requirements.
Effective Corporate Scientific Communication: Strategies to Support your Corporate Narrative and Maximize the Real-World Impact of your Data
This white paper is a companion piece to our popular webinar where we share some of the best approaches we have discovered for Corporate Scientific Communication Strategies.
A Practical Guide: Conducting Systematic Literature Reviews in Support of IVDR Readiness
This white paper is a companion piece to our popular webinar where we break down the steps of the systematic literature review process and take a wholistic approach to conducting an In Vitro Diagnostic Regulation- compliant SLR.
Hidden Traps That Will Derail Your PER
This white paper is a companion piece to our popular webinar that uncovers what we have learned from our experience in writing MDR-compliant CERs, and how urgently applicable some of these key learnings are in preparing a robust Performance Evaluation Report (PER).
