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How to Establish the Competitive Landscape Within the Scientific Validity Report

Webinar , United States

In this practical presentation, Dr. Sarah Chavez, presents a detailed outline of the State-of-the-Art search within the Performance Evaluation Report (PER). Additionally, she will distinguish between the purpose and scope of the state-of-the-art and the Competitor search. For example, the SLR approach, data screening, and data presentation will be addressed. You will learn: The importance […]

Free

[Ask the Expert] Performance Evaluation Report

Virtual Q&A

This session's topic: The Performance Evaluation Report (PER) With the implementation of IVDR requirements, IVD manufacturers have been challenged to align their internal processes and systems to comply with these rigorous regulations. What challenges are you or your team currently facing? Which areas do you need performance evaluation report guidance? During this 45-minute Q&A session, our […]

Free

[Ask the Expert] Performance Evaluation Report

Virtual Q&A

This session's topic: The Performance Evaluation Report (PER) With the implementation of IVDR requirements, IVD manufacturers have been challenged to align their internal processes and systems to comply with these rigorous regulations. What challenges are you or your team currently facing? Which areas do you need performance evaluation report guidance? During this 45-minute Q&A session, our […]

Free

How to Establish the State-of-the-Art Within the Scientific Validity Report

Webinar , United States

How to Establish the State-of-the-Art Within the Scientific Validity Report In this presentation, Criterion Edge’s Principal Medical Writer, Dr. Sarah Chavez, will present focused strategies on building an IVDR-aligned State-of-the-Art (SOA) section within the Scientific Validity Report (SVR). She will also talk about the critical role of the SVR as it relates to the overall performance evaluation […]

How to Establish the Competitive Landscape Within the Scientific Validity Report

Webinar , United States

In this practical presentation, Dr. Sarah Chavez, will present a detailed outline of the IVDR State of the Art search within the Performance Evaluation Report (PER). Additionally, she will distinguish between the purpose and scope of the state-of-the-art and the Competitor search. For example, the SLR approach, data screening, and data presentation will be addressed. […]

Free

Ask the Writers

Virtual Q&A

Ask the Writers: A Comparison of Critical Elements of the Scientific Validity Report vs. the CER State-of-the-Art and Best Practice Writing Strategies In this highly interactive question-and-answer session, Criterion Edge experts Laurie Mitchell, President, and Dr. Sarah Chavez, Director of IVD and Scientific Writing Services, will outline the must-have elements for two very similar regulatory […]

Free
Criterion Edge is a distinguished global provider in the MedTech industry, dedicated to advancing compliance and enhancing market success for Medical Device, Pharma, and IVD companies through expert regulatory, scientific, and clinical writing services.
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