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In this practical presentation, Criterion Edge’s Principal Medical Writer, Dr. Sarah Chavez, presents a detailed outline of the State-of-the-Art search within the Performance Evaluation Report (PER). You will learn how to distinguish between the purpose and scope of the SOA search and the competitor search, in terms of the SLR approach, data screening, and data presentation
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 Scientific Validity Reports for EU IVDR submission, or anyone interested in learning more about the competitive landscape within the SVR.
Who are the Panelists?
Dr. Sarah Chavez, Principal Medical Writer | Criterion Edge
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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?
Click here to watch the recording of this webinar.
Presented from the point of view of seasoned MDR-compliant CER medical writers, this session will present strategies for the verification of IVD clinical performance in the PER. This presentation should help you identify meaningful and measurable performance measures and identify sources of clinical data to support the Clinical Performance Report (CPR).
Key Takeaways
Who Should Watch?
Those Regulatory, Quality and Clinical leaders and teams who are tasked with the development, writing, review or approval of clinical performance reports for IVDR submissions.
Who are the Panelists?
Dr. Sarah Chavez, Principal Medical Writer | Criterion Edge
Sign up for future webinars here.
Criterion Edge has the expertise and resources to do literature reviews for many types of documents. Ready for a free consult?
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?
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In this webinar, we take a deep dive into the best practices to identify appropriate and relevant Safety and Performance Objectives and Acceptance Criteria for your Performance Evaluation Report (PER). First, using a case study example, we discuss considerations and provide tips to help you select relevant Safety and Performance Objectives for your IVD. Next, we discuss how these objectives relate to the competitive landscape and State-of-the-Art (SOA) section of your PER. Finally we explain how these objectives help establish Acceptance Criteria, a critical input for establishing the SOA in your PER.
Key Takeaways
Based on the state of the art:
Who Should Watch?
Those Regulatory, Quality and Clinical leaders and teams who develop, write, review, or approve performance evaluation reports for IVDR submissions, or anyone learning more about PER requirements.
Who are the Panelists?
Dr. Sarah Chavez, Principal Medical Writer | Criterion Edge
Sign up for future webinars here.
Criterion Edge has the expertise and resources to do literature reviews for many types of documents. Ready for a free consult?
Click here to watch the recording of this webinar.
How can scoping help you identify IVDR essentials or critical internal documents needed for IVDR readiness? What are the benefits to beginning the process early? There are many moving pieces needed to write a PER. Therefore we have developed strategies to keep you and your team on track and help assess your own level of preparedness. First, using our CE scoping checklist, we will walk through the necessary documents, SOPs, processes, reports, and templates. Then we will explain how each of these fits into the overall process of preparing to write.
Key Takeaways:
This presentation will emphasize the importance of scoping, discuss how to develop a checklist, and illustrate how scoping may help you identify gaps or missing pieces that could lead to delays or challenges in your PER writing process.
Who Should Watch:
Those Regulatory, Quality and Clinical leaders and teams who are tasked with the development, writing, review or approval of performance evaluation reports for IVDR submissions, and all those interested in learning more about the IVDR essentials needed to write a PER.
Who are the Panelists?
Dr. Sarah Chavez, Principal Medical Writer | Criterion Edge
Sign up for future webinars here.
Criterion Edge has the expertise and resources to do literature reviews for many types of documents. Ready for a free consult?
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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