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.
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?
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