Click here to watch the recording of this webinar.
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
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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.
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?
In Part 1 of our IVD Deep Dive series, we discussed the importance of selecting meaningful performance objectives and explained how these objectives help establish the acceptance criteria. Part 2 of our series will pick up from there with strategies to identify sources of clinical data for your IVD.
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:
Those Regulatory, Quality and Clinical leaders and teams who develop, write, review, or approve clinical performance reports for IVDR submissions.
In vitro diagnostic (IVD) medical devices in the European Union are being held to a higher standard of scrutiny with the introduction of In Vitro Diagnostic Regulation (IVDR) 2017/746 by the European Commission (EC).
The implementation of IVDR dramatically changes the regulatory landscape for IVD medical devices. Some of the biggest changes include an expanded definition of IVDs and a new classification of IVDs. Some other changes are the requirement of Unique Device Identification (UDI) on each device, an expansion of the Quality Management System, and the increased need for Notified Body (NB) review.
The transition into IVDR is already underway. Consequently, IVDs marketed in the EU will continue to require a CE Marking certificate. This is necessary to verify that the device meets all the regulatory requirements. Indeed, failure to meet the IVDR deadlines could be very costly to manufacturers. They would either lose their CE Marking or fail to obtain one.
Read more on this topic in our blog post, here.
Do you have questions about how to generate, collect, analyze, or assess clinical data pertaining to your IVD? What are the best practices for conducting literature searches? How do you effectively present your data in your performance evaluation report? Whether you are just beginning your PER preparations or are already in the process of writing, we will provide insights and suggestions to help make the process of data collection, extraction, and presentation more streamlined.
This forum answers question like these and more. Click here to watch the recording.
The implementation of IVDR requirements has challenged IVD manufacturers to align their internal processes and systems with these rigorous regulations. Therefore, companies realize reviewing published literature for device-specific clinical data to establish the state-of-the-art (scientific validity) is imperative. In addition, establishing clinical performance of their products is key. However, many manufacturers may not be familiar with or have the capability to perform rigorous, IVDR-compliant systematic literature reviews (SLR). Finally, screening, selection and data extraction are typically challenges for manufacturers as well.
In this presentation we break down the steps of the SLR process and take a wholistic approach to conducting an IVDR-compliant SLR. Next, using case studies, we illustrate the effective use of SLR-derived data to develop the Scientific Validity Report (SVR) and the Clinical Performance Report (CPR).
Do you have questions about how to generate, collect, analyze, and assess clinical data pertaining to your IVD or medical device? And what are the best practices for conducting literature searches? How do you effectively present your data in your clinical evaluation report or performance evaluation report?
During this 45-minute Q&A session, our President Laurie Mitchell is joined by Dr. Sarah Chavez to answer some commonly asked questions and give expert advice. Answers cover how to best collect and present data on similar (competitor) devices as well as data collection strategies for new products. In addition, there is discussion around best practices for and examples of appraising literature and clinical data. Also, clarification between safety & performance metrics and risks & benefits analyses is given, plus so much more.
Those Regulatory, Quality and Clinical leaders and teams who develop, write, review or approve clinical evaluation reports or performance evaluation reports for EU MDR or IVDR submissions.
Every day, pharma and medical device companies need data from Systematic Literature Reviews (SLRs) to inform, direct, and help drive their internal processes and decisions. Of course, to comply with global regulatory requirements, clinical literature is also required. Conducting SLRs to search, screen, and extract data from published sources can present challenges to your team in terms of expertise (e.g., medical librarian), methodology, and resources. It takes trained people with the availability to screen, review, and analyze the literature.
Download our free white paper, Systematic Literature Review: How to Empower Data-Driven Decisions in Your Organization to read more on this topic.
You can also watch our webinar on this topic.
Our President Laurie Mitchell joins Jennifer Tetzlaff, Research Product Specialist with Evidence Partners, to talk to you about the following points:
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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