Regulatory Affairs is poised to play a critical role in supporting the current MDR and IVDR required clinical/performance evaluation process, from project implementation through report writing and finally, the on-time submission to the notified body. From the early planning stage through completion of all required written deliverables, this presentation examines key drivers of project success, such as early assessment of data sufficiency, equivalence considerations, internal readiness of critical documentation, project planning strategies, and how to identify potential roadblocks and proactively find solutions to common problems.
Key Takeaways
Identify critical components of the clinical evaluation process that influence project success.
Describe how Regulatory Affairs can support cross-functional stakeholders and lead critical decision-making throughout the clinical evaluation process.
Recognize and implement early mitigation strategies to overcome roadblocks and drive to on-time submission.
Who Should Watch?
Those Regulatory, Quality and Clinical leaders and teams who are tasked with the development, writing, review, or approval of clinical evaluation reports for MDR submissions or performance evaluation reports for IVDR submissions.
In most of our webinars, we’ve focused on the writing process like which steps to take, and how to organize your thoughts onto paper. But we’ve never discussed what happens before the writing process begins. So what do you need before you get started?
In this webinar, we discuss the process of scoping a writing project for either MDR or IVDR. What are the key questions we ask our clients before we start writing and what are the key inputs that are necessary to kickstart the project and ensure you’re starting on the right foot?
Key Takeaways
Planning realistic timelines and assessing your team’s bandwidth to complete this project
Examples of key documents and inputs needed early in the writing process
Describe where these pieces fit within the CER or PER templates
Who Should Watch?
Those regulatory, quality and clinical leaders and teams who are tasked with the development, writing, review, or approval of Clinical Evaluation Reports for MDR submissions or Performance Evaluation Reports for IVDR submissions.
Who are the Panelists?
Dr. Sarah Chavez, Director of IVD & Scientific Writing Services | Criterion Edge
In this highly interactive question-and-answer session, Criterion Edge experts Laurie Mitchell, President, and Dr. Sarah Chavez, Director of IVD and Scientific Writing Services, outline the must-have elements for two very similar regulatory reports: the State-of-the-Art section of an EU MDR-compliant Clinical Evaluation Report (CER) and the EU IVDR Scientific Validity Report (SVR).
Key Takeaways
Understand the required and critical content common to both documents
Learn best-practice writing strategies to support successful completion of these challenging projects
Who Should Watch?
Those regulatory, quality and clinical leaders and teams who are tasked with the development, writing, review, or approval of Clinical Evaluation Reports for MDR submissions or Scientific Validity Reports for IVDR submissions.
Who are the Panelists?
Dr. Sarah Chavez, Director of IVD & Scientific Writing Services | Criterion Edge
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
The importance of the SOA SLR for providing background and general information
How data will be used to establish acceptance criteria
How to assess the safety and performance of your IVD with a systematic approach to the Competitor SLR process
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
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
Discuss the purpose of the CPR and its role as a critical component of the PER
Identify sources of clinical data and analyze those data within the context of the performance endpoints and acceptance criteria presented in the SVR
Demonstrate how to extract, organize, and appraise these data within the CPR
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
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.
Are You Reg. Ready? Get your medical affairs team primed to manage new regulatory requirements
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.
Driving Innovation to Success in the Market: Strategic Considerations
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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