Safety and performance objectives…..clinical outcomes…..clinical benefits…..acceptance criteria…..risk-benefit ratio. These terms represent key concepts of the Clinical Evaluation Report (CER), yet confusion still exists on how to effectively identify, present and analyze these parameters within the context of an MDR-compliant CER. How do they tie together? How do they help you “tell the story” of the CER?
Click here to watch the recording of this session.
Presented from the point of view of seasoned MDR-compliant CER medical writers, this session will take a practical approach to:
There will be time at the end of this session to ask questions. Please submit your questions ahead of time while registering for this session so we have ample time to answer them thoughtfully. You may choose to send in your questions during the presentation as well.
Those Regulatory, Quality and Clinical leaders and teams who develop, write, review, or approve clinical evaluation reports for MDR submissions. Anyone interested in learning more about MDR requirements for CERs is also welcome to attend. Also, we encourage professionals from the IVD industry to attend as well, as the content is also relevant to IVDR requirements, which align closely with MDR.
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.
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.
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?
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:
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?
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.
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.
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.
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.
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.
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.
Fill out this form, or contact us at info@criterionedge.com, and we would be happy to answer any of your questions as well as book you an appointment to discuss your project needs during a time that works for you.
In this discussion, we provide an overview of how to plan and coordinate change within an organization to meet upcoming EU IVDR regulatory requirements. We will be highlighting key steps involved in helping medical affairs transition to a more rigorous regulatory environments, and how to evaluate talent gaps, team leadership composition, and process challenges of your product portfolio.
In this discussion, our panel of proven leaders discuss the key elements that support and propel the innovation process in the medical device, pharmaceutical, and IVD industries. We will be highlighting key areas of the process, important players in the pathway to the market, and how successful innovations spawn new innovations in new markets such as the digital health space, and more.
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