August 5, 2021

[FREE WEBINAR] How to Establish the State of the Art Within the Scientific Validity Report

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In this practical presentation, Criterion Edge presents focused strategies on building an IVDR-aligned State of the Art (SOA) section within the Scientific Validity Report (SVR). We also talk about the critical role of the SVR as it relates to the overall performance evaluation process.

Key Takeaways:

  • The foundational role of the SOA in the SVR
  • The required components of the SOA such as the safety and performance objectives
  • The importance of a robust systematic literature review (SLR) to support your SOA

Who Should Watch:

  • Those Regulatory, Quality and Clinical leaders and regulatory writers who are tasked with the development, writing, review or approval of Scientific Validity Reports for EU IVDR submission, or anyone interested in learning more about the SOA section within the SVR.

Who are the Panelists?

Dr. Sarah Chavez, Principal Medical Writer | 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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July 9, 2021

[FREE WEBINAR] Are You Reg. Ready? Get your medical affairs team primed to manage new regulatory requirements.

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There’s been plenty of discussion on the submission scope of current EU MDR and pending EU IVDR regulatory requirements for medical device manufactures. But what of organizational change management readiness? How should a medical device organization’s different business functions collaborate and align their people, processes, and knowledge to meet these regulatory requirements effectively and efficiently?

Watch the recorded webinar for a behind the scenes look at how one company is managing change within their organization. Dr. Imelda Omana-Zapata, BD Senior Manager Clinical Projects, will provide an overview of how she is planning and coordinating change within her organization to meet upcoming EU IVDR regulatory requirements. Laurie Mitchell, Founder and President of Criterion Edge, will discuss the critical technology and expertise required to meet more rigorous scientific validated submissions to notify bodies.

Key Takeaways:

  • Key steps involved in helping medical affairs transition to a more rigorous regulatory environments.
  • How to evaluate talent gaps, team leadership composition, and process challenges of your product portfolio.
  • Critical systematic literature review technology and experience required to ensure CER and PER submissions are audit-ready and compliant.

Who Should Watch:

  • Medical Device & Diagnostics Professionals (from small-medium sized to large enterprises)

Who are the Panelists?

Laurie Mitchell, President | Criterion Edge
Dr. Imelda Omana-Zapata, Senior Manager, Clinical Projects | BD

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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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June 17, 2021

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

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In this live discussion, our panel of proven leaders discuss the key elements that support and propel the innovation process in the medical device, pharmaceutical, and IVD industries. We will be highlighting key areas of the process, important players in the pathway to the market, and how successful innovations spawn new innovations in new markets such as the digital health space, and more.

Who are the panelists?

Laurie Mitchell, President | Criterion Edge
Caroline Byrd,  VP of Regulatory, Quality, and Clinical | Nextern 
Dr. Krishna Sudhir, Divisional VP, Medical Affairs and Product Performance | Abbott Vascular 
Sidney Collin, Cofounder and CEO | De Oro Devices

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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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May 24, 2021

[FREE WEBINAR SERIES] How to Assess Your CER for MDR Readiness

In the first installment of this webinar series, Criterion Edge presents strategies for assessing key components of your CER (or CER template) for possible misalignment with significant and applicable MDR requirements. This practical presentation will help you assess your document through the critical lens of a writer and identify possible gaps for mitigation before submission to regulatory authorities.

In the second installment, we continue to present strategies for assessing key components of your CER for possible misalignment with key EU MDR requirements, examining the clinical data sources, equivalence, and risk/benefit analysis profile sections of the CER.

Finally, in the third presentation we share with you some of the biggest issues we have discovered when starting an MDR CER project based on our experiences with clients both large and small, and we also reveal some of the most successful strategies in addressing these issues, up-front and early.

Click here to watch our free webinar series to develop MDR-ready CERs.

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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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