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.
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?
This session is presented from the point of view of seasoned MDR-compliant CER medical writers. In this 45-minute live Q&A, we will answer questions regarding critical concepts for a clinical evaluation report template such as safety and performance objectives, clinical outcomes, clinical benefits, acceptance criteria, and risk-benefit ratio. We hope to provide you with best practices and writing strategies to support solid planning during your own writing process.
During this session, come prepared with your questions for our experts to answer. Please submit your questions ahead of time while registering for this session so we have ample time to answer them thoughtfully. Also, please be aware that answers will be limited to 3 minutes per question.
This forum will answer questions on a first come first serve basis, so please submit all your questions when you register for this event.
Click here to watch the recording of this session.
Those Regulatory, Quality and Clinical leaders and teams who develop, write, review, or approve clinical evaluation reports for MDR submissions or performance evaluation reports for IVDR submissions.
Are you looking for best tips on how to create a robust systematic literature review process? And maybe even an informative case study illustrating the process? Watch our webinar on effective systematic literature review for post-market surveillance to understand how to continually support your device once your clinical evaluation report is completed and submitted. Learn how leveraging published data can help meet regulatory expectations and inform internal decision-making, the steps for conducting a methodologically-sound SLR, and even how data obtained through SLR can empower the successful execution of post-market surveillance activities, drive efficiencies, and support regulatory compliance.
Do you know how to identify meaningful safety and performance endpoints (measures/objectives)? Are you confidently able to demonstrate that your safety and performance objectives are appropriate and clinically relevant?
Download our free white paper, a companion piece to our popular webinar where we cover strategies to verify device safety and performance in the clinical evaluation of medical and in vitro diagnostic (IVDs) devices. This white paper should help you with identifying meaningful safety and performance measures for clinical or performance evaluation. It will also help with defining acceptance criteria parameters to determine the acceptability of benefit-risk as mandated by Medical Device Regulation (MDR) 2017/745 and In Vitro Diagnostic Regulation (IVDR) 2017/746.
Safety and performance objectives…..clinical outcomes…..clinical benefits…..acceptance criteria…..risk-benefit ratio. These terms represent key concepts of the Clinical Evaluation Report (CER), yet confusion still exists on how to effectively identify, present and analyze these parameters within the context of an MDR-compliant CER. How do they tie together? How do they help you “tell the story” of the CER?
Click here to watch the recording of this session.
Presented from the point of view of seasoned MDR-compliant CER medical writers, this session will take a practical approach to:
There will be time at the end of this session to ask questions. Please submit your questions ahead of time while registering for this session so we have ample time to answer them thoughtfully. You may choose to send in your questions during the presentation as well.
Those Regulatory, Quality and Clinical leaders and teams who develop, write, review, or approve clinical evaluation reports for MDR submissions. Anyone interested in learning more about MDR requirements for CERs is also welcome to attend. Also, we encourage professionals from the IVD industry to attend as well, as the content is also relevant to IVDR requirements, which align closely with MDR.
This white paper is a companion piece to our popular webinar where we cover strategies to verify device safety and performance in the clinical evaluation of medical and in vitro diagnostic (IVDs) devices. This white paper should help you with identifying meaningful safety and performance measures for clinical or performance evaluation and with defining acceptance criteria parameters to determine the acceptability of benefit-risk as mandated by Medical Device Regulation (MDR) 2017/745 and In Vitro Diagnostic Regulation (IVDR) 2017/746.
Establishing your device’s safety and performance is a critical component of the clinical evaluation process. However, how to use the state of the art section within the Clinical Evaluation Report (CER) and Performance Evaluation Report (PER) to establish the device’s safety and performance objectives and acceptance criteria can seem ambiguous.
Join us on Wednesday, June 7th, 2023 at 11 AM PST, as our regulatory experts discuss the process of writing a PER, with careful attention to the importance of aligning technical documents to create a cohesive, well-organized report.
Spots are limited – click to register for this free webinar.
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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