How to Assess Your CER for MDR Readiness, Part 1

How to Assess Your CER for MDR Readiness, Part 1

57:58 |

Related Videos

Pro Tips Unveiled: Expert Systematic Literature Review Strategies for EU IVDR Submissions

58:44

Pro Tips Unveiled: Expert Systematic Literature Review Strategies for EU IVDR Submissions

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

54:42

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

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

56:59

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

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

56:40

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

Interview with Laurie Mitchell | President at Criterion Edge

8:05

Interview with Laurie Mitchell | President at Criterion Edge

Considerations for Companion Diagnostics: Lessons Learned and Key Takeaways from DIA 2024

52:08

Considerations for Companion Diagnostics: Lessons Learned and Key Takeaways from DIA 2024

Demonstration of Sufficient Evidence & Regulatory Strategy Alignment in Clinical Evaluation Process

59:29

Demonstration of Sufficient Evidence & Regulatory Strategy Alignment in Clinical Evaluation Process

Intro to Adverse Event Reviews [WEBINAR RECORDING] | Criterion Edge Webinar Series

49:22

Intro to Adverse Event Reviews [WEBINAR RECORDING] | Criterion Edge Webinar Series

10th class math |chapter 6|Triangles|Theorem 6.5|SAS Similarity Criterion |CBSE|NCERT|

15:12

10th class math |chapter 6|Triangles|Theorem 6.5|SAS Similarity Criterion |CBSE|NCERT|

IVDR Readiness: Creating a Blueprint to Build a Strong PER

56:02

IVDR Readiness: Creating a Blueprint to Build a Strong PER

IVDR Essentials: Performance Evaluation Report - Early Planning and Preparation

58:25

IVDR Essentials: Performance Evaluation Report - Early Planning and Preparation

Ask the Expert: Clinical Evaluation, Measurable Objectives, and Acceptance Criteria

46:54

Ask the Expert: Clinical Evaluation, Measurable Objectives, and Acceptance Criteria

IVD Deep Dive Part 1: Safety and Performance Objectives and Acceptance Criteria

56:24

IVD Deep Dive Part 1: Safety and Performance Objectives and Acceptance Criteria

Stay Focused: The Purpose of the SVR and Tips for Building a Strong PER Foundation

57:37

Stay Focused: The Purpose of the SVR and Tips for Building a Strong PER Foundation

New Requirements for In Vitro Diagnostics: Lessons Learned from the AAMI/FDA/BSI Annual Conference

58:36

New Requirements for In Vitro Diagnostics: Lessons Learned from the AAMI/FDA/BSI Annual Conference

Criterion Edge "Proof of Concept" part 1

2:09

Criterion Edge "Proof of Concept" part 1

Hidden Traps That Will Derail Your CER: Answer these critical questions before you start writing

59:04

Hidden Traps That Will Derail Your CER: Answer these critical questions before you start writing

Ask the Expert: Understanding Clinical Data Sufficiency and Limited Clinical and Performance Data

43:25

Ask the Expert: Understanding Clinical Data Sufficiency and Limited Clinical and Performance Data

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

42:50

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

Critical Concepts: Deep Dive into MDR and IVDR Device Classification and Data Collection Strategies

56:52

Critical Concepts: Deep Dive into MDR and IVDR Device Classification and Data Collection Strategies