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?
At the beginning of the month, Criterion Edge’s Director of IVD & Scientific Writing Services, Dr. Sarah Chavez, alongside the VP of Sales & Marketing, Cheryl VanAllen, represented the company at the 16th Annual Q1 Productions Conference for IVD Clinical and Regulatory Affairs.
As the regulatory landscape evolves globally, this was an important conference for in vitro diagnostic (IVD) manufacturers and service providers to meet and discuss how to stay ahead of the curve to ensure compliance with new regulations. Criterion Edge discussed the EU IVDR and how it presents a significant challenge for regulatory and clinical affairs professionals in the diagnostic industry, as they must navigate a complex web of regulations across multiple regions, including the EU, UK, Switzerland, Canada, China, and the US.
At this event, Sarah and Cheryl attended case study presentations and panel discussions that covered the latest global regulatory changes and compliance strategies. They even focused on the growing concerns around cybersecurity breaches and how the diagnostic industry has also had to respond to new regulations aimed at maintaining cybersecurity standards. Overall, the conference offered a unique opportunity for diagnostic regulatory and clinical affairs executives to network and share knowledge, making it a fantastic networking and educational opportunity.
Laurie Mitchell, Criterion Edge President, and Kaylla Hall, Account Manager, joined leaders in life sciences medical communications at the 11th Annual Life Science Medical Communications Conference hosted by Q1 Productions in Boston last month. Together they shared their expertise and experiences on streamlining communication in healthcare. At this event, they participated in case studies and group discussions that covered a variety of topics, such as incorporating digital capabilities into publication operations, ensuring compliance in disease awareness communications, and developing effective engagement strategies for patients and external stakeholders.
Through discussions with industry professionals, they shared valuable insights on streamlining and enhancing medical communication operations with an emphasis on well-written plain language summaries for the lay audience and healthcare providers. Since the program hosted an intimate group, it fostered a sense of collaboration and allowed Laurie and Kaylla to connect with peers and expert presenters in a collaborative environment. Additionally, the networking opportunities brought Criterion Edge some great new connections that we are excited to partner with!
Click here to watch the recording of this webinar.
The goal of performance evaluation is to show that your IVD performs as intended and meets the acceptance criteria, therefore establishing that your IVD may be considered state of the art. Remember: the PER is a product, but it is documenting a process. Performance evaluation can be straightforward if your analyte has a well-established association with a clinical condition. But how should you approach the SVR when there is too much or not enough data?
This webinar will discuss the role of data sufficiency, the importance of developing a solid strategy to establish scientific validity, how gaps in the SVR can significantly impact the quality of the PER, and how proper scoping can help maximize success when it comes to a performance evaluation.
Key Takeaways
Who are the Panelists?
Sarah J. Chavez, Director, IVD & Scientific Writing Services, Criterion Edge
Sign up for future webinars here.
Criterion Edge has the expertise and resources to write your scientific validity report 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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