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 26, 2022

[Ask the Expert] Safety & Performance (IVDR)

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 45-minute Q&A session, our experts answer commonly asked questions like these and more. 

Who should watch the recording?

Those Regulatory, Quality and Clinical leaders and teams who develop, write, review or approve performance evaluation reports for IVDR submissions. 

Click here to watch the recording of this webinar and get answers to commonly asked questions before the IVDR date of application.

IVDR Compliance: Insights Gained from Writing MDR-Compliant CERs that Can Be Leveraged to Meet IVDR Requirements

In vitro diagnostic (IVD) medical device manufacturers are scrambling to meet the In Vitro Diagnostic Regulation (IVDR) 2017/746 requirements imposed by the European Union (EU). Changes in IVD classification require the majority of IVDs currently marketed in the EU to undergo notified body scrutiny under IVDR and obtain CE marking, yet few guidance documents have been released. Lessons learned from meeting Medical Device Regulation (MDR) 2017/745 can help pave the way.

One thing is clear, if you have not yet started, time is running out. The May 26, 2022 Date of Application is a hard deadline. Applicable IVDs that are not certified under the IVDR by this deadline cannot be sold on the EU market.  Read our 5 tips to successfully meet the IVDR deadline here.

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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

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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September 2, 2021

[Ask the Expert] Measurable Objectives and Acceptance Criteria

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 how to identify meaningful safety and performance endpoints. In addition, she discusses how to demonstrate safety and performance objectives are appropriate and clinically relevant as well as what acceptance criteria is and how to define it.

Who should watch this webinar?

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. If you attended our hour-long webinar on August 25, but we did not answer your questions we encourage you to attend to get your questions answered on this topic.

Watch the recording!

Clearly Defining Measurable Safety and Performance Endpoints

All medical devices selling in Europe must have a Clinical Evaluation Report (CER). Specific and measurable safety and performance endpoints are paramount for an acceptable CER. However, many small medical device manufacturers are struggling to adequately define and subsequently document measurable safety and performance endpoints, especially in the literature review, to support an evidence-based evaluation

The newest regulations for medical devices, Medical Device Regulation (MDR) 2017/745 and MEDDEV 2.7/1 revision 4, set high standards for confirming safety and performance according to the manufacturer’s Instructions for Use. Previously, regulations under the old MDR and MEDDEV were not as demanding. Also, manufacturers are not accustomed to the current systematic process of CER evaluations. 

Read more on this topic in our recent blog post, Clearly Defining Measurable Safety and Performance Endpoints in Clinical Evaluation Reports (CER) is a Real Challenge for Medical Device Manufacturers.

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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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