[Ask the Expert] The Importance of Clinical Data

Virtual Q&A

This session's topic: The Importance of Clinical Data: Sources of Data, Literature Searches, Weighting & Appraisal and Effective Presentation in your CER or PER During this 30 minute Q&A session, our President Laurie Mitchell answers questions on how to generate, analyze, and assess clinical data pertaining to your IVD or medical device. In addition, she […]

[Ask the Expert] The Importance of Clinical Data

Virtual Q&A

The Importance of Clinical Data: Sources of Data, Literature Searches, Weighting & Appraisal and Effective Presentation in your CER or PER Do you have questions about how to generate, collect, analyze, and assess clinical data pertaining to your IVD or medical device? And what are the best practices for conducting literature searches? How do you […]

Free

[Ask the Expert] Clinical Data for IVD

Virtual Q&A

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 […]

Free

IVD Deep Dive Series Part 2

Webinar , United States

Clinical Data Sources: Leveraging Clinical Data in the Clinical Performance Report In Part 1 of our IVD Deep Dive series, we discussed the importance of selecting meaningful performance objectives and explained how these objectives help establish the acceptance criteria. Part 2 of our series will pick up from there with strategies to identify sources of […]

Bridging the Gaps: Clinical Data for GSPRs

Webinar , United States

Bridging the Gaps: Determining Clinical Data Sufficiency to Demonstrate Conformity with GSPRs What do I do if there is no data for my device? This is a concern we hear quite often from clients. MDR states that device groups may not require clinical investigations if sufficient clinical evidence exists and the device meets specific criteria. […]

Free

Demonstration of Sufficient Evidence and Regulatory Strategy Alignment in the Clinical Evaluation Process

Webinar , United States

Demonstration of Sufficient Evidence and Regulatory Strategy Alignment in the Clinical Evaluation Process  In the first part of our webinar series, we discussed Legacy Devices, WET devices, and devices exempt from Clinical Investigations under Article 61, along with the need for data sufficiency and how significant changes impact the route to conformity. In this webinar, […]

Free

CER Critical Concepts

Webinar , United States

Clinical Evaluation Report Critical Concepts: Effectively Telling the Story of the CER - Focus on S&P Objectives, Acceptance Criteria, Clinical Benefits and Risk-Benefit Analysis Safety and performance objectives…..clinical outcomes…..clinical benefits…..acceptance criteria…..risk-benefit ratio. These terms represent key concepts of the Clinical Evaluation Report (CER), yet confusion still exists on how to effectively identify, present and analyze […]

Free

Critical Concepts: The Role of Post Market Surveillance in Establishing Data Sufficiency

Webinar , United States

Critical Concepts: The Role of Post Market Surveillance in Establishing Data Sufficiency In this webinar, we will review the conformity requirements for “legacy devices” under the MDR and “established devices” under the IVDR to help you harness the potential of effective post market activities. We will discuss how “legacy devices," defined as those previously certified […]

Free