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.

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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: 

• Is my software considered a medical device? 
• How do I address the clinical evaluation for my medical device software? 
• How do I define the safety and performance outcomes, and other clinical evaluation parameters? 

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?