MDR Webinars

Name: The Role of RA in the Clinical and Performance Evaluation Process
Start: 2022-06-15T11:00:00-07:00
End: 2022-06-15T12:00:00-07:00
Location: Webinar

August 2021
Clinical Evaluation: Measurable Objectives and Acceptance Criteria to Verify Device Safety and Performance
Featured August 25, 2021 @ 11:00 AM - 12:00 PM PDT

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
[Ask the Expert] The Importance of Clinical Data
August 26, 2021 @ 11:00 AM - 11:30 AM PDT

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 […]
September 2021
[Ask the Expert] Systematic Literature Review
September 1, 2021 @ 11:00 AM - 11:45 AM PDT

Virtual Q&A
This session's topic: Systematic Literature Review: What is it and why is it so important? Do you have specific questions about the steps of the systematic literature review process or questions regarding your medical device or IVD? During this 45-minute Q&A session, our President Laurie Mitchell answers questions about the steps to conduct a methodologically […]
Free
[Ask the Expert] Measurable Objectives and Acceptance Criteria
Featured September 2, 2021 @ 11:00 AM - 11:45 AM PDT

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
September 22, 2021 @ 10:00 AM - 10:45 AM PDT

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
November 2021
[Ask the Expert] The Importance of Clinical Data
November 3, 2021 @ 11:00 AM - 11:45 AM PDT

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] Safety and Performance
November 17, 2021 @ 11:00 AM - 11:45 AM PST

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 […]
February 2022
[Ask the Expert] Safety and Performance (MDR)
February 9, 2022 @ 11:00 AM - 11:45 AM PST

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 […]
April 2022
[Ask the Expert] Common Notified Body Review Findings
April 28, 2022 @ 11:00 AM - 11:45 AM PDT

Virtual Q&A
This session's topic: Tips For How to Avoid Common Notified Body Review Findings Criterion Edge is often approached by clients with MDR Clinical Evaluation Reports (CERs) that require extensive revisions based upon Notified Body review and feedback. Addressing NB feedback costs your team time and effort and may threaten critical submission deadlines. However many of […]
Free
May 2022
Ask the Writers
May 18, 2022 @ 11:00 AM - 11:45 AM PDT

Virtual Q&A
Ask the Writers: A Comparison of Critical Elements of the Scientific Validity Report vs. the CER State-of-the-Art and Best Practice Writing Strategies In this highly interactive question-and-answer session, Criterion Edge experts Laurie Mitchell, President, and Dr. Sarah Chavez, Director of IVD and Scientific Writing Services, will outline the must-have elements for two very similar regulatory […]
Free
June 2022
Scoping Your MDR & IVDR Writing Projects
June 1, 2022 @ 11:00 AM - 12:00 PM PDT

Webinar , United States
Scoping Your MDR and IVDR Writing Projects - The Forgotten Step In most of our webinars, we’ve focused on the writing process including which steps to take and how to organize your thoughts onto paper. However, we’ve never discussed what happens before the writing process begins. So what do you need before you get started? […]
Free
The Role of RA in the Clinical and Performance Evaluation Process
June 15, 2022 @ 11:00 AM - 12:00 PM PDT

Webinar , United States
The Role of Regulatory Affairs in the Clinical and Performance Evaluation Process: Key Strategies to Support Project Success Regulatory Affairs plays a critical role in supporting the current MDR and IVDR required clinical/performance evaluation process, from project implementation through report writing and finally, the on-time submission to the notified body. From the early planning stage […]
Free

August 2021

September 2021

November 2021

February 2022

April 2022

May 2022

June 2022