April 22, 2021

[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. 

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Criterion Edge provides free scoping of your PERs. Is it time to get them reviewed? Book your free consult.

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March 18, 2021

[FREE WEBINAR] Leveraging the MDR experience for IVDR: Tips for Successful Performance Evaluation and PMS/PMPF Processes

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

Have the IVDR Performance Evaluation and Post Market Surveillance requirements got you tied up in knots? Where do you start? What does the end product look like? In this presentation, President Laurie Mitchell is joined by Caroline Byrd, the VP of Regulatory, Quality, and Clinical from Nextern, a collaborative medical device company bringing unmatched core competence in medical device product design and development. Watch this discussion of their experiences supporting clients through MDR and IVDR requirements.

Who should watch?

All regulatory, clinical, and scientific professionals who are tasked with the development, writing, review or approval of scientific manuscripts, reports, presentations, and other forms of communications in the medical device, pharmaceutical, and diagnostics space. 

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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