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Scoping Your MDR and IVDR Writing Projects - The Forgotten Step
In most of our webinars, we’ve focused on the writing process including which steps to take and how to organize your thoughts onto paper. However, we’ve never discussed what happens before the writing process begins. So what do you need before you get started?

In this webinar, we’ll discuss the process of scoping a writing project for either MDR or IVDR. We will share the key questions we ask our clients before we start writing and what key inputs are necessary to kickstart the project and ensure you’re starting on the right foot.

We hope to
- Give insight into planning realistic timelines and assessing your team’s bandwidth to complete your project
- Provide examples of key documents and inputs needed early in the writing process
- Describe where these pieces fit within the Clinical Evaluation Report or Performance Evaluation Report templates

There will be time at the end of the presentation for our speakers to answer your questions. Please submit all your questions when registering for this webinar.

Who is this webinar for?
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. Anyone interested in learning more about the requirements for these reports is also welcome to attend.

Jun 1, 2022 11:00 AM in Pacific Time (US and Canada)

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Webinar is over, you cannot register now. If you have any questions, please contact Webinar host: Olivia Miele.