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
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
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
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:
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?
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?
Click here to watch the recording of this webinar.
In case you are wondering if Medical Device Software (MDSW/SaMD) and digital health content is a hot topic, the FDA released 4 guidance documents in 2022 alone, on topics ranging from cyber security, medical image devices, and mobile medical applications. Furthermore, the European MDR- EU 2017/745 and new IVDR – EU 2017/746 regulation contain stipulations related to how software is regulated, classified, and qualified.
You may be asking yourselves:
Click the link above to get answers to these questions and to find out more about the topic of software as a medical device.
Who are the Panelists?
Laurie Mitchell, President of Criterion Edge, and Stacie Beecham
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?
Fill out this form, or contact us at info@criterionedge.com, and we would be happy to answer any of your questions as well as book you an appointment to discuss your project needs during a time that works for you.
In this discussion, we provide an overview of how to plan and coordinate change within an organization to meet upcoming EU IVDR regulatory requirements. We will be highlighting key steps involved in helping medical affairs transition to a more rigorous regulatory environments, and how to evaluate talent gaps, team leadership composition, and process challenges of your product portfolio.
In this 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.
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