[FREE WEBINAR] State of the Art: Building a Solid Foundation for your PER to Support IVDR Readiness

Get a copy of the slides from this webinar or click to watch the recording.

In this presentation, we provide an overview of the State of the Art section, and explain how it fits into the overall process of writing a successful, IVDR-compliant Performance Evaluation Report (PER) in a reasonable time frame. A complete readiness assessment and gap analysis will help you identify critical resources, feeder documents, and expertise needed to establish that your IVD may be considered “state-of-the-art.” Ultimately, knowing what the Notified Body expects to see will help you avoid project delays and discover efficiencies in the SOA development process.

Key Takeaways:

  • The importance of planning and preparation before you even begin to actually write the SOA 
  • The complete outline of the SOA literature review and assessment process to understand “documentation” needs and what the Notified Body may be expecting to see as part of the Scientific Validity Report (SVR)
  • The potential impact your PER in case of incorrect/incomplete documents or processes

Who should watch this webinar? 

Those Regulatory, Quality and Clinical leaders and regulatory writers who are tasked with the development, writing, review or approval of Performance Evaluation Reports for EU IVDR submission, or anyone interested in learning more about IVDR requirements for PERs. 

Sign up for future webinars here.


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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[WEBINAR] Driving Innovation to Success in the Market: Strategic Considerations.

Join us for our LIVE webinar on June 16, 2021, at 11AM PST / 2 Pm EST. In this engaging panel discussion, four industry professionals will discuss the key elements that support and propel the innovation process in the medical device, pharmaceutical, and IVD industries as well as key areas of the process, important players in the pathway to the market, and how successful innovations spawn new innovations in new markets.

Attendees are eligible for a free consultation. Spots are limited – click to register for this free webinar.