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

Webinar , United States

Clinical Evaluation: Measurable Objectives and Acceptance Criteria to Verify Device Safety and Performance In this presentation we discuss strategies for the verification of device safety and performance in the clinical evaluation. Our seasoned CER medical writers are rooted in MDR-compliant practices. Likewise, this presentation will help you identify meaningful safety and performance measures for the […]

Free

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[Ask the Expert] Measurable Objectives and Acceptance Criteria

Virtual Q&A

This session's topic: Clinical Evaluation: Measurable Objectives and Acceptance Criteria to Verify Device Safety and Performance Are you looking for strategies for the verification of device safety and performance in the clinical evaluation? Are you struggling to define device safety and performance objectives? During this 45-minute Q&A session, our President Laurie Mitchell answers questions regarding […]

Free

[Ask the Expert] Safety and Performance

Virtual Q&A

This session's topic: Safety and Performance Measures and Acceptance Criteria Do you have questions about how to identify meaningful safety and performance measures for the clinical evaluation? What are the best strategies for the verification of device safety and performance? During this 45-minute Q&A session, our President Laurie Mitchell answers questions on how to identify […]

Free

[Ask the Expert] Safety and Performance

Virtual Q&A

This session's topic: Safety and Performance Measures and Acceptance Criteria Do you have questions about how to identify meaningful safety and performance measures for the clinical evaluation? What are the best strategies for the verification of device safety and performance? Are you demonstrating that your safety and performance objectives are appropriate and clinically relevant​? Do […]

[Ask the Expert] Safety & Performance (IVDR)

Virtual Q&A

This session's topic: Safety and Performance Objectives and Acceptance Criteria for IVDR Do you have questions about how to establish meaningful safety and performance measures for the performance evaluation? What are the best methods and practices for identifying acceptance criteria? Are you demonstrating that your safety and performance objectives are appropriate and clinically relevant​? During this […]

[Ask the Expert] Safety and Performance (MDR)

Virtual Q&A

This session's topic: Safety and Performance Measures and Acceptance Criteria for MDR Do you have questions about how to identify meaningful safety and performance measures for the clinical evaluation? What are the best strategies for the verification of device safety and performance? Are you demonstrating that your safety and performance objectives are appropriate and clinically […]

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IVDR Essentials: Performance Evaluation Report – Early Planning and Preparation

Webinar , United States

IVDR Essentials: Performance Evaluation Report - Early Planning and Preparation In this webinar, we discuss the importance of scoping to help you identify critical internal documents needed for IVDR-readiness. First, we know a PER has many moving pieces. Accordingly, we'll present strategies to keep you and your team on track and help assess your own […]

IVD Deep Dive Series Part 1

Webinar , United States

Safety & Performance Objectives and Acceptance Criteria How do I define acceptance criteria and how do I define safety and performance objectives? What are the biggest pitfalls or "Achille's heels" to watch out for in identifying safety and performance measures? In this webinar, we'll take a deep dive into the best practices to identify relevant […]

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 […]

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

Criterion Edge is a distinguished global provider in the MedTech industry, dedicated to advancing compliance and enhancing market success for Medical Device, Pharma, and IVD companies through expert regulatory, scientific, and clinical writing services.
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