Click here to watch the recording of this webinar.

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. 

Who are the Panelists?

Dr. Sarah Chavez, Director of IVD and Scientific Writing Services. 

Laurie Mitchell, President of Criterion Edge.

Sign up for future webinars here.


Criterion Edge has the expertise and resources to write your clinical or performance evaluation report. Ready for a free consult

June 29, 2023

[FREE WEBINAR] It’s All Interconnected: Hidden Traps That Can Derail Your PER: Lessons Learned from the MDR-Compliant CER Writing Experience

Click here to watch the recording of this webinar.

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. 

Who are the Panelists?

Dr. Sarah Chavez, Director of IVD and Scientific Writing Services. 

Laurie Mitchell, President of Criterion Edge.

Sign up for future webinars here.


Criterion Edge has the expertise and resources to write your clinical or performance evaluation report. Ready for a free consult

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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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June 13, 2023

[FREE WEBINAR] IVDR Readiness: Creating a Blueprint to Build a Strong PER

Click here to watch the recording of this webinar.

The IVDR has many companies scrambling and feeling a bit disorganized. The new regulations include multiple technical documents, as well as the Performance Evaluation Report (PER). But how do all of these pieces fit together? Given the large volume of submissions that Notified Bodies will be reviewing, and the short review times, organization and clarity are critical for the success of your application.  

In this webinar, we discuss the process of writing a PER, with careful attention to the importance of aligning technical documents to create a cohesive, well-organized report. Based on our experience with both the MDR and IVDR, we will discuss timelines, resources, and strategies to build a strong foundation to support your IVDR writing team.  

Who are the Panelists?

Dr. Sarah Chavez, Director of IVD and Scientific Writing Services. 

Sign up for future webinars here.


Criterion Edge has the expertise and resources to write your clinical or performance evaluation report. Ready for a free consult

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May 5, 2023

[FREE WEBINAR] Integration of Plain Language Content and Infographics into HCP Communication Channels: Strategies to Enhance HCP Engagement

 

Click here to watch the recording of this webinar.

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 communication can help ensure key health information and clinical research findings are understandable and accessible to all.  

But you might wonder “Isn’t plain language intended only for patient and caregiver consumption?  HCPs want factual, scientifically rigorous content, not the simplified messaging of plain language writing.”  The answer is…. not always.  The deliberate and targeted incorporation of plain language content into selected HCP communication channels can be an effective tool in your omnichannel communication plan.   

Join us as we present information you can use to develop effective HCP-focused plain language content such as: 

  • Key elements of plain language content – what it is and what it isn’t
  • How incorporation of plain language content into HCP-focused assets can create added value in HCP – patient interactions
  • Common content formats that can be enhanced by the use of plain language content
  • The elements of the Visual SRD and why HCPs prefer this format
  • How innovative use of plain language and infographics in HCP communications can support Medical Affairs as part of its omnichannel communication framework. 

Who are the Panelists?

Laurie Mitchell, President of Criterion Edge.

Sign up for future webinars here.


Criterion Edge has the expertise and resources to write your clinical or performance evaluation report. Ready for a free consult?

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April 6, 2023

[FREE WEBINAR] Developing Effective Patient-Focused Content: Writing Plain Language Lay Summaries and SSCP Patient Sections

 

Click here to watch the recording of this webinar.

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 communication can help ensure key health information and clinical research findings are understandable and accessible to all. 
 
In this second presentation of our Deep-Dive: Plain Language Writing webinar series, we will focus on best practices that guide the development of common forms of plain language communication intended for the patient, their families and/or caregivers, such as the: 
• Patient section of an EU MDR-compliant Summary of Safety and Clinical Performance (SSCP) for all Class III and Active Implantable Medical Devices (AIMD) 
• Plain Language Summary (PLS) of a published journal article 
• Lay summaries required under EU CTR for clinical trials on medicinal products

Join us as we discuss practical strategies you can use to develop effective patient-centered lay summary content.

Who are the Panelists?

Laurie Mitchell, President of Criterion Edge.

Sign up for future webinars here.


Criterion Edge has the expertise and resources to write your clinical or performance evaluation report. Ready for a free consult?

 

 

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