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?
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?
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 what is the purpose of the SVR, and how should you approach it 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.
In this webinar, you will learn
1. How to clearly define what information should (and shouldn’t) be presented within the Scientific Validity Report.
2. How the systematic literature review process supports and connects the SVR, CPR, and APR by leveraging published data.
3. How to conduct gap assessments to assess IVDR readiness and develop strategies to increase efficiencies in the performance evaluation process to support the SVR.
At the end of the presentation, we will dedicate 15 minutes to answering your questions. Please submit your questions beforehand if you have any to help us prepare. Also, you can submit your questions at any point during the presentation.
Click here to watch the recording of this webinar.
In October 2022, the AAMI/FDA/BSI Annual Conference discussed current knowledge and practical strategies to meet new IVDR clinical evidence requirements. Dr. Sarah Chavez, Criterion Edge Director of IVD Writing Services, was invited to speak with other regulatory, notified body and industry leaders as panelists at the pre-conference workshop “New Requirements for In Vitro Diagnostics”.
Watch Dr. Chavez’s recent webinar and benefit from key insider insights gleaned from this meeting. Sarah shares and discusses the key take-aways from the Symposium, including clinical evidence requirements and strategies to keep your report writing and data collection on track. Many companies are in the early stages of planning for IVDR, so take a step towards IVDR readiness with these helpful suggestions for planning and preparation from the perspective of experienced regulatory writers.
In this webinar, we will review the conformity requirements for “legacy devices” under the MDR and “established devices” under the IVDR to help you harness the potential of effective post market activities. We will discuss how “legacy devices,” defined as those previously certified under MDD/AIMDD, can demonstrate conformity to the general safety and performance requirements under the MDR through a collection of pre-market and post-market data.
Additionally, we will touch on some examples of the types of clinical data that are appropriate to use for “legacy devices” for both MDR and IVDR requirements, and finally we will review the MDCG 2020-6 guidance on clinical data for “legacy devices.”
There will be time at the end of the presentation to get your questions answered. Please submit your questions beforehand if you have any to help us prepare. You can also submit your questions during the presentation.
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 anyone interested in learning more about these requirements. Those from the IVD space are welcome to attend as this information may also be relevant.
Joining Criterion Edge’s President Laurie Mitchell, is guest speaker, Queenita Fernandes, Medtronic’s Medical Safety Manager, Patient Monitoring & Respiratory Interventions. In this webinar, we discuss how to deploy systematic literature review in order to augment post market clinical surveillance, and share best tips on a robust systematic literature review process. Following this, our guest speaker shares an informative case study illustrating more.
Key Takeaways:
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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