[FREE WEBINAR] Scoping Your MDR and IVDR Writing Projects – The Forgotten Step

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

  • 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

Laurie Mitchell, President | Criterion Edge

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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?

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[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.

Spots are limited – click to register for this free webinar.

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