[FREE WEBINAR] IVD Deep Dive Series Part 2

By: Sarah VanVickle Chaves, Director of IVD and Scientific Writing Services, Ph.D. Molecular and Cellular Biology

Key Takeaways

  • Discuss the purpose of the CPR and its role as a critical component of the PER ​
  • Identify sources of clinical data and analyze those data within the context of the performance endpoints and acceptance criteria presented in the SVR​
  • Demonstrate how to extract, organize, and appraise these data within the CPR​

Who Should Watch?

Those Regulatory, Quality and Clinical leaders and teams who are tasked with the development, writing, review or approval of clinical performance reports for IVDR submissions.

Who are the Panelists?

Dr. Sarah Chavez, Principal Medical Writer | Criterion Edge


Criterion Edge has the expertise and resources to do literature reviews for many types of documents. Ready for a free consult?

 

TALK TO AN EXPERT

Whether you’re navigating a complex regulatory submission, preparing for an audit, or simply exploring outsourced support — our team is here to help.

Criterion Edge specializes in high-quality, compliant medical writing services for the life sciences industry. Use the form to tell us a bit about your needs — one of our experts will follow up within one business day.

Need a faster response? Use the chat icon in the lower-right corner to speak with us immediately during business hours.

  • No obligation — just an open conversation
  • Expert guidance from PhD-level writers
  • Trusted by leading MedTech & Pharma companies
  • Fast turnaround for time-sensitive projects
  • Clear quotes and scoping available

How Can We Help?

TALK TO AN EXPERT

Whether you’re navigating a complex regulatory submission, preparing for an audit, or simply exploring outsourced support — our team is here to help.

Criterion Edge specializes in high-quality, compliant medical writing services for the life sciences industry. Use the form to tell us a bit about your needs — one of our experts will follow up within one business day.

Need a faster response? Use the chat icon in the lower-right corner to speak with us immediately during business hours.

  • No obligation — just an open conversation
  • Expert guidance from PhD-level writers
  • Trusted by leading MedTech & Pharma companies
  • Fast turnaround for time-sensitive projects
  • Clear quotes and scoping available

How Can We Help?

We're headed to the 18th Annual Outsourcing in Clinical Trials New England · Visit Us At Booth 76A.

UPCOMING WEBINAR: Beyond AI: Why the Future of Scientific and Regulatory Writing Is Human + AI · October 28 · 8 AM PDT · 10 AM CDT · 11 AM EDT

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