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?
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
[Free Webinar] Ask the Expert: Clinical Evaluation Report Critical Concepts
Join us on Wednesday October 10th, 2022 at 11AM PST / 2PM EST, as President Laurie Mitchell answers your questions regarding safety and performance objectives, clinical outcomes, clinical benefits, acceptance criteria, and risk-benefit ratio. Learn best practices and writing strategies to support solid planning during your own writing process.
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