March 28, 2022

[FREE WHITE PAPER] Measurable Objectives and Acceptance Criteria to Verify Device Safety and Performance

Overview

This white paper is a companion piece to our popular webinar where we cover strategies to verify device safety and performance in the clinical evaluation of medical and in vitro diagnostic (IVDs) devices. This white paper should help you with identifying meaningful safety and performance measures for clinical or performance evaluation and with defining acceptance criteria parameters to determine the acceptability of benefit-risk as mandated by Medical Device Regulation (MDR) 2017/745 and In Vitro Diagnostic Regulation (IVDR) 2017/746.

Establishing your device’s safety and performance is a critical component of the clinical evaluation process. However, how to use the state of the art section within the Clinical Evaluation Report (CER) and Performance Evaluation Report (PER) to establish the device’s safety and performance objectives and acceptance criteria can seem ambiguous.

Solution to Verify Device Safety and Performance

First, clearly understand the difference between safety and performance objectives and acceptance criteria. Then, use…

Download the rest of this white paper here.


Criterion Edge has the expertise and resources to write your Clinical Evaluation or Performance Evaluation Report. Ready for a free consult?

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January 20, 2022

[FREE WEBINAR] Post-Market Literature Surveillance: Systematic Literature Review and Case Study

Click here to watch the recording of this webinar.

Joining Criterion Edge’s President Laurie Mitchell, is guest speaker, Queenita Fernandes, Medtronic’s Medical Safety Manager, Patient Monitoring & Respiratory Interventions​. In this webinar, we discuss how to deploy systematic literature review in order to augment post market clinical surveillance, and share best tips on a robust systematic literature review process. Following this, our guest speaker shares an informative case study illustrating more.

Key Takeaways:

  • How leveraging published data can help meet regulatory expectations and inform internal decision-making​
  • Steps for conducting a methodologically-sound SLR​
  • How data obtained through SLR can empower the successful execution of post-market surveillance activities, drive efficiencies and support regulatory compliance. 

Who Should Watch:

Those Regulatory, Quality and Clinical leaders and regulatory writers who are tasked with the development, writing, review or approval of Clinical Evaluation Reports for EU MDR submission, or anyone interested in learning more about MDR requirements for CERs.

Who are the Panelists?

Laurie Mitchell, President | Criterion Edge

Queenita Fernandes, Medical Safety Manager | Medtronic

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Criterion Edge has the expertise and resources to do literature reviews for many types of documents. Ready for a free consult?

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August 26, 2021

[FREE WEBINAR] Clinical Evaluation: Measurable Objectives and Acceptance Criteria to Verify Device Safety and Performance

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

Click here to watch the recording of this webinar.

This webinar is presented from the point of view of seasoned MDR-compliant CER medical writers. Criterion Edge discusses strategies for the verification of device safety and performance in the clinical evaluation. Next, we teach you how to identify meaningful safety and performance measures for the clinical evaluation and define parameters to determine the acceptability of benefit-risk.

Key Takeaways:

Based on the state-of-the-art

  • Identify meaningful safety and performance endpoints (measures/objectives) 
  • Demonstrate that safety and performance objectives are appropriate and clinically relevant 
  • Specify acceptance criteria that are used to determine the acceptability of benefit-risk 

Who Should Watch:

Those Regulatory, Quality and Clinical leaders and regulatory writers who develop, write, review or approve Clinical Evaluation Reports for EU MDR submission. Additionally, anyone interested in learning more about MDR requirements for CERs is encouraged to watch as well. Finally, we encourage viewers from the IVD industry as well, as the content is relevant to IVDR requirements, which align closely with MDR. 

Who are the Panelists?

Laurie Mitchell, President | Criterion Edge

Sign up for future webinars or view our events calendar.


Criterion Edge has the expertise and resources to do literature reviews for many types of documents. Ready for a free consult?

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