June 23, 2023

It’s All Interconnected: Hidden Traps That Can Derail Your 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. In this practical presentation, Criterion Edge uncovers what we have learned from our experience in writing MDR-compliant CERs, and how urgently applicable some of these key learnings are in preparing a robust Performance Evaluation Report (PER).  

This presentation provides practical tips on how to assess for hidden traps and unexpected roadblocks that could impact the success of writing an IVDR-compliant PER. By performing a gap analysis and assessing the readiness and availability of critical resources, documents and expertise, you will be able to avoid project delays and discover efficiencies that will enable the on-time completion of a successful, IVDR-compliant PER. 

Learning Objectives: 

  • The importance of scoping your PER project in advance  
  • The critical inputs needed to enable the success of your PER and the impact to the project if these inputs are not available or incomplete  
  • How to identify those hidden gaps in resources and information and the steps to take to mitigate them

Click here to watch the webinar recording and download the presentation slides.

Who is this webinar for?

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

Ask the Expert: Plain Language Written Content for Multiple Audiences: Effective Communication for Patients, Caregivers, and HCPs

Healthcare companies continually strive to communicate important information about their drugs and devices to diverse audiences comprised of patients, caregivers, healthcare professionals (HCPs), and the general public. The use of plain language written content ensures key health information and clinical research findings are understandable and accessible to all.

Click here to watch this recent webinar to learn key elements of plain language written content, how to identify the target audience, selecting the most appropriate dissemination channels for the information, the challenges to produce a multitude of plain language written deliverables for multiple audiences, and more.

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February 9, 2022

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

Click here to watch the recording of this webinar.

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

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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August 5, 2021

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

Click here to watch the recording of this webinar.

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

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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July 9, 2021

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

Click here to watch the recording of this webinar.

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

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

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

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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