Do you have specific questions about the steps of the systematic literature review process or questions regarding your medical device or IVD? During this 45-minute Q&A session, our President Laurie Mitchell answers questions about the steps to conduct a methodologically sound SLR. In addition, she discusses how to leverage published data to meet regulatory expectations and inform internal decision-making from marketing initiatives and clinical strategies to global regulatory requirements.
Those Regulatory, Quality and Clinical leaders and teams who develop, write, review or approve Systematic Literature Reviews for EU MDR or IVDR submissions, meta-analyses, regulatory response support, development of clinical marketing materials, etc.
With the implementation of IVDR and MDR requirements, device manufacturers often struggle to align their internal processes and systems to comply with these rigorous regulations. Consequently, companies realize the need to review published literature for device-specific clinical data. However many manufacturers may not be familiar with or have the capability to perform all steps of the rigorous systematic literature review process, including screening, selection and data extraction.
Watch our webinar where we break down the steps of the SLR process and take a wholistic approach to conducting an IVDR-compliant SLR. Using case studies, the presentation illustrates the effective use of SLR-derived data to develop the Scientific Validity Report (SVR) and the Clinical Performance Report (CPR). We encourage professionals from the medical device industry to watch as well, as the content is also relevant to MDR requirements, which align closely with IVDR.
This white paper is a companion piece to our popular webinar where we share our insights on using the Systematic Literature Review (SLR) to Empower Data-Driven Decisions in your Organization.
Every day, pharma and medical device companies need data from SLRs to inform, direct, and help drive their internal processes and decisions that move their companies forward. Of course, clinical literature is also required for compliance with global regulatory requirements. Conducting SLRs to search, screen, and extract data from published sources can present challenges to your team in terms of expertise (e.g., medical librarian), methodology, and resources. It takes trained people with the availability to screen, review, and analyze the literature.
Adopting a transparent, reproducible, and robust process for SLRs is essential to …
Download the rest of this white paper here.
Criterion Edge has the expertise and resources to do literature reviews for many types of documents. Ready for a free consult?
Get a copy of the slides from this webinar or click to watch the recording.
With the implementation of IVDR requirements and 2022 deadline approaching, IVD manufacturers have been challenged to align their internal processes and systems to comply with these rigorous regulations. In this practical presentation, Criterion Edge uncovers what we have learned from our experience in writing MDR-compliant CERs, and how urgently applicable some of these key learnings are in preparing a robust Performance Evaluation Report (PER).
Key Takeaways:
•The importance of scoping your PER project in advance
•The critical inputs needed to enable the success of your PER and the impact to the project if these inputs are not available or incomplete
•How to identify those hidden gaps in resources and information and the steps to take to mitigate them
Who should watch this webinar?
Those Regulatory, Quality and Clinical leaders and regulatory writers who are tasked with the development, writing, review or approval of Performance Evaluation Reports for EU IVDR submission, or anyone interested in learning more about IVDR requirements for PERs.
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?
Get a copy of the slides from this webinar or click to watch the recording.
With the implementation of IVDR requirements, IVD manufacturers have been challenged to align their internal processes and systems to comply with these rigorous regulations. In this practical presentation, Criterion Edge uncovers what we have learned from our experience in writing MDR-compliant CERs, and how urgently applicable some of these key learnings are in preparing a robust Performance Evaluation Report (PER).
Who should watch this webinar?
Those Regulatory, Quality and Clinical leaders and regulatory writers who are tasked with the development, writing, review or approval of Performance Evaluation Reports for EU IVDR submission, or anyone interested in learning more about IVDR requirements for PERs.
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?
Get a copy of the slides from this webinar or click to watch the recording.
You have planned a time to complete your Clinical Evaluation Reports to meet the upcoming MDR deadline, but when your team sits down to write, will they have everything they need to complete the job?
As we all know, the MDR has significantly increased both the quality and quantity of inputs needed to complete a CER. This takes more up-front planning than the reports have in the past, and the last thing you want to do is torpedo your writing project timeline by not having everything your team needs when that project begins.
Based on our experiences with clients both large and small, our President, Laurie Mitchell, will share with you some of the biggest issues we have discovered when starting an MDR CER project. And Laurie will also reveal some of the most successful strategies in addressing these issues, up-front and early.
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?
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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