Name: Scoping Your MDR & IVDR Writing Projects
Start: 2022-06-01T11:00:00-07:00
End: 2022-06-01T12:00:00-07:00
Location: Webinar

How to Establish the Competitive Landscape Within the Scientific Validity Report

IVD Deep Dive Series Part 2

Clinical Evaluation: Measurable Objectives and Acceptance Criteria to Verify Device Safety and Performance

This white paper outlines strategies for the verification of device safety and performance as well as tips to define parameters to determine the acceptability of benefit-risk.

Post-Market Literature Surveillance: Systematic Literature Review and Case Study

[Ask the Expert] Safety and Performance Measures and Acceptance Criteria for MDR

[Ask the Expert] Safety and Performance Measures and Acceptance Criteria for IVDR

[Ask the Expert] Clinical Data for IVD: What Is It and How Do I Find It?

IVD Deep Dive Series Part 1

IVDR Essentials: Performance Evaluation Report - Early Planning and Preparation

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

Clinical Evaluation: Measurable Objectives and Acceptance Criteria to Verify Device Safety and Performance

[Ask the Expert] The Importance of Clinical Data: Sources of Data, Literature Searches, Weighting & Appraisal and Effective Presentation in your CER or PER

[Ask the Expert] Clinical Evaluation: Measurable Objectives and Acceptance Criteria to Verify Device Safety and Performance

[Ask the Expert] Systematic Literature Review: What is it and why is it so important?

How to Establish the Competitive Landscape Within the Scientific Validity Report

[Ask the Expert] Safety and Performance Measures and Acceptance Criteria

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

[Ask the Expert] Performance Evaluation Report

[Ask the Expert] Performance Evaluation Report

[Ask the Expert] The Importance of Clinical Data: Sources of Data, Literature Searches, Weighting & Appraisal and Effective Presentation in your CER or PER

[Ask the Expert] Safety and Performance Measures and Acceptance Criteria

A Practical Guide: Conducting Systematic Literature Reviews in Support of IVDR Readiness [Free Webinar]

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).

Systematic Literature Review: Empower Data-Driven Decisions White Paper

This white paper is a companion piece to our popular webinar where we share our insights on using the Systematic
Literature Review (SLR) to Empower Data-Driven Decisions in your Organization.

Systematic Literature Review: How to Empower Data-Driven Decision Making [Free Webinar]

In this webinar, we share the process of systematic literature review, and discuss the tools and best practices for creating a methodologically-sound systematic literature review.

State of the Art: Building a Solid Foundation for your PER to Support IVDR Readiness

In this webinar, Dr. Sarah Chavez provides an overview of the State of the Art section, and explains how it fits into the overall process of writing a successful, IVDR-compliant Performance Evaluation Report (PER) in a reasonable time frame. A complete readiness assessment and gap analysis will help you identify critical resources, feeder documents, and expertise needed to establish that your IVD may be considered “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.

A Practical Guide: Conducting Systematic Literature Reviews for IVDR Readiness

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.

State of the Art: Establishing a Solid Foundation for Your PERs to Encourage IVDR Readiness

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).

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Schedule a Free Consult Today!

Fill out this form, or contact us at info@criterionedge.com, and we would be happy to answer any of your questions as well as book you an appointment to discuss your project needs during a time that works for you.

Are You Reg. Ready? Get your medical affairs team primed to manage new regulatory requirements

In this discussion, we provide an overview of how to plan and coordinate change within an organization to meet upcoming EU IVDR regulatory requirements. We will be highlighting key steps involved in helping medical affairs transition to a more rigorous regulatory environments, and how to evaluate talent gaps, team leadership composition, and process challenges of your product portfolio.

Effective Corporate Scientific Communications White Paper

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.

Driving Innovation to Success in the Market: Strategic Considerations

In this discussion, our panel of proven leaders discuss the key elements that support and propel the innovation process in the medical device, pharmaceutical, and IVD industries. We will be highlighting key areas of the process, important players in the pathway to the market, and how successful innovations spawn new innovations in new markets such as the digital health space, and more.

Hidden Traps That Will Derail Your PER White Paper

This white paper is a companion piece to our popular webinar that uncovers what we have learned from our experience in writing Medical Device Regulation (MDR)-compliant Clinical Evaluation Reports (CERs), and how urgently applicable some of these key learnings are in preparing a robust Performance Evaluation Report (PER).

Hidden Traps That Will Derail Your CER White Paper

This white paper is a companion piece to our popular webinar where we share some of the biggest issues we have discovered when starting a Clinical Evaluation Report (CER) project, and how to anticipate and avoid project delays.

How to Assess Your CER for MDR-Readiness Part 2

This companion piece to our popular webinar discusses strategies for assessing key components of your CER like clinical data sources and risk-benefit analysis.

How to Assess Your CER for MDR-Readiness Part 1

This white paper outlines strategies to assess your CER including state of the art, safety and performance criteria, equivalence and systematic literature review.

Leveraging the MDR experience for IVDR: Tips for Successful Performance Evaluation and PMS/PMPF Processes [Free Webinar]

Have the IVDR Performance Evaluation and Post Market Surveillance requirements got you tied up in knots? Where do you start? What does the end product look like? We are joined by the VP of Regulatory, Quality, and Clinical from Nextern, a collaborative medical device company bringing unmatched core competence in medical device product design and development. Criterion Edge’s President Laurie Mitchell will lead a discussion of their experiences supporting clients through MDR and IVDR requirements.

Effective Corporate Scientific Communication: Strategies to Support your Corporate Narrative and Maximize the Real-World Impact of your Data [Free Webinar]

In this practical presentation, President Laurie Mitchell will: 1) discuss how an effective scientific communication plan is an important marketing tool for an organization, and 2) present five strategies to ensure your corporate objectives are supported and maximize the real-world impact of your data. Join us to learn how this applies to your organization and how to implement these strategies into your current processes.

Hidden Traps That Derail PER Preparedness: Lessons Learned from the MDR-Compliant CER Writing Experience [Free Webinar]

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).

Hidden Traps That Can Derail Your CER: Answer These Critical Questions Before You Start Writing [Free Webinar]

As we all know, the MDR has significantly increased both the quality and quantity of inputs needed to complete a CER, needing more up-front planning than the reports have in the past. 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.

How to Assess Your CER for MDR Readiness, Part 2 [Free Webinar]

In this second installment of our 2-part webinar series, Criterion Edge shares practical presentation to help you assess your CER through the critical lens of a writer and identify possible gaps for mitigation before prior to submission to regulatory authorities.

Systematic Literature Review: How to Empower Data-Driven Decision Making [Free Webinar]

In this webinar, we share the process of systematic literature review, and discuss the tools and best practices for creating a methodologically-sound systematic literature review.

Experience and Scalability

Watch this video to learn how Criterion Edge is different from the rest.

5 Key Questions to Help Manage Your Budget

This infographic goes through 5 key questions to go through in order to control your budget.

Examining the Implications of the MDR on Data Management

Leading industry experts come together to discuss how the MDR affects data management within their respective units.

MedDev 2.7/1 Guideline: Equivalence and Risk/Benefit Profile

This report clarifies the modifications to the equivalence guidelines in MEDDEV 2.7/1 and Quality Management Systems (QMS) ISO 13485 standard to help develop strategies.

MedDev 2.7/1 Guideline: Qualifications of Evaluators and Scientific Validity

This gap analysis addresses key revisions to evaluator qualifications and scientific validity in the Clinical Evaluation (CE) MEDDEV guideline rev.4.

MedDev 2.7/1 Guideline: More Clinical Evaluations?

The changes to 2.7/1 rev. 4 suggest the need to submit more frequent CERs to regulatory authorities, however, strategies will be discussed for managing the increased requirements.

Data Mining: New Initiatives on Health Care Data that Manufacturers Should be Watching

Every time a healthcare provider makes a notation in the medical chart, a significant and valuable piece of data has been created. This paper discusses the implications of this.

10 Strategies to Build Efficiencies in your Regulatory Writing Process

This piece discusses 10 key strategies to building an efficient regulatory writing process.

State of the Art: Best Practices and Literature Review Using DistillerSR

In this paper, we discuss a prominent clarification on the MEDDEV 2.7.1 rev 4, establishing the “state of the art” section.

Q&A Follow-Up: How to Assess Your CER for MDR Readiness, Part 1 [Free Webinar]

The overwhelming turnout at the ‘How to Assess Your CER for MDR Readiness, Part 1’ prompted us to host a live Q+A session where President Laurie Mitchell exclusively answers all your questions.

Systematic Literature Review To Help Meet MDR Requirements [Free Webinar]

President Laurie Mitchell returns to continue sharing more about the importance of the systematic literature review.

State of the Art Literature Review for EU MDR Compliance: How To Get It Right [Free Webinar]

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.

How to Assess Your CER for MDR Readiness, Part 1 [Free Webinar]

In this first installment of a 2-part webinar series, Criterion Edge will present strategies for assessing key components of your CER (or CER template) for possible misalignment with significant and applicable MDR requirements.

Intro to Adverse Event Reviews [Free Webinar]

In this webinar, President Laurie Mitchell discusses why safety reviews are essential in the entire life cycle of product development.

Advantages to Technologies Supporting Endpoint Adjudication [Free Webinar]

Kyoko Hattori from Criterion Edge returns to discuss best practices for managing the adjudication process in-house, and Brian Kelly from AG Mednet will share how the “JUDI” platform can simplify the management of adjudication.

Endpoint Adjudication by the Clinical Endpoints Committee (CEC) [Free Webinar]

In this webinar, learn about CECs, familiarization with regulatory guidance, decision factors leading to use of a CEC, and much more.

June 2022