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How do you determine which content applies to each classification? How do you address data insufficiency for a WET or Legacy device? In this webinar, our medical regulatory experts, Dr. Sarah Chavez and Stacie Beecham, answer these questions and outline how to ensure your regulatory strategy will adequately support the clinical evaluation specific to your device.
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 evaluation reports for MDR submissions.
Who are the Panelists?
Dr. Sarah Chavez, Director of IVD & Scientific Writing Services
Stacie Beecham, Principal Medical Writer
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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.
What do I do if there is no data for my device? This is a concern we hear quite often from clients. MDR states that device groups may not require clinical investigations if sufficient clinical evidence exists, and the device meets specific criteria. In this webinar, we discuss the concept of data sufficiency. Specifically, we explain the differences between a well-established technology and a legacy device as defined by MDR and discuss strategies from both a regulatory and writer’s perspective.
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 evaluation reports for MDR submissions.
Who are the Panelists?
Dr. Sarah Chavez, Director of IVD & Scientific Writing Services
Stacie Beecham, Principal Medical Writer
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.
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
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?
Laurie Mitchell, President | 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.
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
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
Laurie Mitchell, President | 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.
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
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
Laurie Mitchell, President | 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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