November 17, 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.

Categories:
Do you like it?0
September 22, 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.

Categories:
Do you like it?0
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?

Categories:
Do you like it?0
June 8, 2021

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

Author: Suzanne Broussard, PhD  | June 8, 2021

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 will 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.  

Here we share our insights learned from writing many MDR-compliant Clinical Evaluation Reports (CERs) in the context of IVD medical devices and the looming IVDR deadline. 

(more…)
Categories:
Do you like it?0
May 24, 2021

[FREE WEBINAR SERIES] How to Assess Your CER for MDR Readiness

In the first installment of this webinar series, Criterion Edge presents strategies for assessing key components of your CER (or CER template) for possible misalignment with significant and applicable MDR requirements. This practical presentation will help you assess your document through the critical lens of a writer and identify possible gaps for mitigation before submission to regulatory authorities.

In the second installment, we continue to present strategies for assessing key components of your CER for possible misalignment with key EU MDR requirements, examining the clinical data sources, equivalence, and risk/benefit analysis profile sections of the CER.

Finally, in the third presentation we share with you some of the biggest issues we have discovered when starting an MDR CER project based on our experiences with clients both large and small, and we also reveal some of the most successful strategies in addressing these issues, up-front and early.

Click here to watch our free webinar series to develop MDR-ready CERs.

(more…)
Categories:
Do you like it?0