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Medical device manufacturers and pharma/biotech companies have a regulatory and legal obligation to convert key scientific content into plain language for lay audience consumption around the world. From producing clinical trial lay summaries for the general public to the action-focused informational content generation aimed at the Health Care Provider (HCP) audience, the need to produce a multitude of plain language written deliverables has strained many already-stretched internal teams. How can your organization meet these challenges?
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.
Content is the user experience. Make your words count.
Key Takeaways
Who are the Panelists?
Laurie W. Mitchell, President, Criterion Edge
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Criterion Edge has the expertise and resources to do literature reviews for many types of documents. Ready for a free consult?
Click here to watch the recording of this webinar.
The In Vitro Diagnostics Regulation (IVDR) took effect in May 2022 and has introduced substantial changes in the regulatory framework for in vitro diagnostic medical devices (IVDs) in Europe. IVD manufacturers are expected to meet more rigorous standards for clinical evidence, with up to 80% of IVDs requiring Notified Body certificates under IVDR.
In October 2022, the AAMI/FDA/BSI Annual Conference sought to discuss current knowledge and practical strategies to meet these new clinical evidence requirements. Dr. Sarah Chavez, Criterion Edge Director of IVD Writing Services, was honored to be an invited speaker and join with other regulatory, notified body and industry leaders as panelists at the pre-conference workshop “New Requirements for In Vitro Diagnostics”.
Attendees to this Criterion Edge webinar will benefit from key insider insights gleaned from this meeting, as Sarah will be share and discuss the key take-aways from the Symposium, including clinical evidence requirements and strategies to keep your report writing and data collection on track. Most companies are in the early stages of planning for IVDR, so the goal of this webinar is to provide helpful suggestions for IVDR planning and preparation from the perspective of experienced regulatory writers.
Key Takeaways
Who Should Watch?
Those Regulatory, Quality, and Clinical leaders and teams who are tasked with the development, writing, review, or approval of performance evaluation reports for IVDR submissions.
Who are the Panelists?
Dr. Sarah Chavez, Director, IVD & Scientific Writing Services
Sign up for future webinars here.
Criterion Edge has the expertise and resources to do literature reviews for many types of documents. Ready for a free consult?
The In Vitro Diagnostics Regulation (IVDR) took effect in May 2022 and has introduced substantial changes in the regulatory framework for in vitro diagnostic medical devices (IVDs) in Europe. IVD manufacturers are expected to meet more rigorous standards for clinical evidence, with up to 80% of IVDs requiring Notified Body certificates under IVDR.
In October 2022, the AAMI/FDA/BSI Annual Conference sought to discuss current knowledge and practical strategies to meet these new clinical evidence requirements. Dr. Sarah Chavez, Criterion Edge Director of IVD Writing Services, was honored to be an invited speaker. She joined with other regulatory, notified body and industry leaders as panelists at the pre-conference workshop “New Requirements for In Vitro Diagnostics”.
Attendees to this webinar will benefit from key insider insights gleaned from the Annual Conference, as Sarah will be share and discuss the key take-aways from the Symposium, including clinical evidence requirements and strategies to keep your report writing and data collection on track. Since most companies are in the early stages of planning for IVDR, the goal of this webinar is to provide helpful suggestions for IVDR planning and preparation from the perspective of experienced regulatory writers.
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 register for this session.
Those Regulatory, Quality and Clinical leaders and teams who develop, write, review or approve performance evaluation reports for IVDR submissions, or anyone looking to learn more about new requirements for in vitro diagnostics.
In vitro diagnostic (IVD) medical devices in the European Union are being held to a higher standard of scrutiny with the introduction of In Vitro Diagnostic Regulation (IVDR) 2017/746 by the European Commission (EC).
Overview of In Vitro Diagnostic Regulation 2017/746
The implementation of IVDR dramatically changes the regulatory landscape for IVD medical devices. Some of the biggest changes include an expanded definition of IVDs, a new classification of IVDs, the requirement of Unique Device Identification (UDI) on each device, an expansion of the Quality Management System, and the increased need for Notified Body (NB) review.
The transition into IVDR is already underway. IVDs marketed in the EU will continue to require a CE Marking certificate to verify that the device meets all the regulatory requirements. Failure to meet the IVDR deadlines could be very costly to manufacturers that would either lose their CE Marking or fail to obtain one. Click here to read the full blog post that outlines the deadlines for manufacturers to become compliant with IVDR 2017/746.
In September 2022, European Commissioners published updates to the Manual on Borderline and Classification for Medical Devices, which provides clarifications for classifying devices as medical or in vitro diagnostic devices under the MDR and IVDR. This guidance describes how to distinguish medical devices from medicinal products, biocides, and personal protective equipment, and how to distinguish between in vitro diagnostic medical devices and general laboratory equipment.
This “Critical Concepts” webinar will discuss rules for device classification under each regulation, as well as the risk-based classification rules as described in MDCH 2021-24 and MDCG 2020-16. Our “Deep Dive” will provide insights into the potential impact of risk-based classifications on your data collection strategies to support data sufficiency in the CER and PER.
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. Also, you can submit your questions at any point during the presentation.
Click here to register for this session.
Those Regulatory, Quality and Clinical leaders and teams who are tasked with the development, writing, review, or approval of clinical evaluation reports for MDR submissions or performance evaluation reports for IVDR submissions. Anyone interested in learning more about these requirements is welcome to attend.
In vitro diagnostic (IVD) medical devices in the European Union are being held to a higher standard of scrutiny with the introduction of In Vitro Diagnostic Regulation (IVDR) 2017/746 by the European Commission (EC).
Overview of In Vitro Diagnostic Regulation 2017/746
The implementation of IVDR dramatically changes the regulatory landscape for IVD medical devices. Some of the biggest changes include an expanded definition of IVDs, a new classification of IVDs, the requirement of Unique Device Identification (UDI) on each device, an expansion of the Quality Management System, and the increased need for Notified Body (NB) review.
The transition into IVDR is already underway. IVDs marketed in the EU will continue to require a CE Marking certificate to verify that the device meets all the regulatory requirements. Failure to meet the IVDR deadlines could be very costly to manufacturers that would either lose their CE Marking or fail to obtain one. Click here to read the full blog post that outlines the deadlines for manufacturers to become compliant with IVDR 2017/746.
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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