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 covered/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. 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?
Who should watch this session?
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
|June 1st, 2022||Watch at a Convenient Time||Virtual|
Give insight into planning realistic timelines and assessing your team’s bandwidth to complete this project
Provide examples of key documents and inputs needed early in the writing process
Describe where these pieces fit within the CER or PER templates