August 12, 2021

[Ask the Expert] Safety and Performance

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 you know how to specify acceptance criteria that are used to determine the acceptability of benefit-risk?

During this presentation, President Laurie Mitchell and Principal Medical Writer, Dr. Sarah Chavez, answer questions on how to identify meaningful safety and performance endpoints, ensure they are appropriate and clinically relevant, how to specify acceptance criteria ranges, and more.

Who should watch the recording?

Those Regulatory, Quality and Clinical leaders and teams who develop, write, review or approve Clinical Evaluation or Performance Evaluation Reports for EU MDR or IVDR submissions

Click here to watch the recording!

Clearly Defining Measurable Safety and Performance Endpoints

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.  

These relatively new requirements for clinical evaluation extend to manufacturers sending new products into the European market. Additionally, those that are already selling medical devices will have to follow these new requirements. Safety and performance are central components of the evidence-based evaluation process for obtaining and maintaining CE Marking for MDR 2017/745 and MEDDEV 2.7/1 rev 4. Consequently, medical device manufacturers felt the pressure to comply by May 2021.

Read more on this topic in our blog post, here.

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August 12, 2021

[Ask the Expert] Safety and Performance

safety and performance measures

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 meaningful safety and performance endpoints. In addition she discusses how to demonstrate that S&P endpoints are appropriate and clinically relevant​, as well as how to specify acceptance criteria to determine the acceptability of benefit-risk.

Who should watch this webinar?

Those Regulatory, Quality and Clinical leaders and teams who develop, write, review or approve Clinical Evaluation Reports for EU MDR or IVDR submissions

Watch the recording!

Clearly Defining Measurable Safety and Performance Endpoints

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.  

These relatively new requirements for clinical evaluation extend to manufacturers sending new products into the European market. Additionally, those that are already selling medical devices will have to follow these new requirements. Safety and performance are central components of the evidence-based evaluation process for obtaining and maintaining CE Marking for MDR 2017/745 and MEDDEV 2.7/1 rev 4. Consequently, medical device manufacturers felt the pressure to comply by May 2021.

Read more on this topic in our blog post, here.

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July 29, 2021

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

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 clinical evaluation. In addition, we will define parameters to determine the acceptability of benefit-risk. Afterwards, we will have about 10-15 minutes to answer any questions you may have on this topic.

Who should watch the recording?

Those Regulatory, Quality and Clinical leaders and teams who develop, write, review or approve CERs for EU MDR submission. Anyone interested in learning more about MDR requirements for CERs is encouraged to come too. We encourage attendees from the IVD industry to attend as well, as the content is also relevant to IVDR requirements, which align closely with MDR.

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, here.

Want to read the highlights to verifying your device’s safety and performance? Download our white paper where we give your the best approaches to finding measurables objectives and acceptance criteria for your medical device.

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July 21, 2021

[FREE WHITE PAPER] State of the Art: Establishing a Solid Foundation For Your PERs to Encourage IVDR Readiness

Overview

This white paper is a companion piece to our popular webinar where we cover the state of the art process and how it fits into the In Vitro Diagnostic Regulation (IVDR).

Manufacturers are expected to demonstrate a thorough clinical evaluation of the IVD in the context of what is generally acknowledged to reflect the most current best-practice science. To establish that your IVD is SOA, you must be able to show how it fits into the entire scientific landscape and explain the circumstances and diagnostic scenarios by which the IVD can be considered SOA.

Solution

Knowing what the Notified Body expects to see will help you avoid …

Download the rest of this white paper here.


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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June 5, 2020

[FREE WEBINAR] Live Q&A Follow-Up: How to Assess Your CER for MDR Readiness, Part 1

Q&A Follow Up with Laurie

Click here to watch the recording.

We had such a large turnout at our previous webinar, How to Assess Your CER for MDR Readiness, Part 1, and left with some questions unanswered. Therefore, President Laurie Mitchell held a live Q&A to respond to questions regarding CER for MDR Readiness. In this webinar, Laurie delves deeper into some of your pressing questions like:

  • Would you recommend using clinical data from systematic reviews and meta-analyses to support the safety and performance of the subject device? 
  • Do you compare warnings and precautions as part of clinical equivalence? 
  • Can you give an example of a safety/performance objective and corresponding acceptance criteria?  

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.

Sign up for future webinars here.


If you enjoyed this webinar and would like a free consultation, please contact us here.

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