In this practical presentation, Criterion Edge presents focused strategies on building an IVDR-aligned State of the Art (SOA) section within the Scientific Validity Report (SVR). We also talk about the critical role of the SVR as it relates to the overall performance evaluation process.
Key Takeaways:
The foundational role of the SOA in the SVR
The required components of the SOA such as the safety and performance objectives
The importance of a robust systematic literature review (SLR) to support your SOA
Who Should Watch:
Those Regulatory, Quality and Clinical leaders and regulatory writers who are tasked with the development, writing, review, or approval of Scientific Validity Reports for EU IVDR submission, or anyone interested in learning more about the SOA section within the SVR.
Who are the Panelists?
Dr. Sarah Chavez, Principal Medical Writer | Criterion Edge
In this practical presentation, Criterion Edge presents focused strategies on building an IVDR-aligned State of the Art (SOA) section within the Scientific Validity Report (SVR). We also talk about the critical role of the SVR as it relates to the overall performance evaluation process.
Key Takeaways:
The foundational role of the SOA in the SVR
The required components of the SOA such as the safety and performance objectives
The importance of a robust systematic literature review (SLR) to support your SOA
Who Should Watch:
Those Regulatory, Quality and Clinical leaders and regulatory writers who are tasked with the development, writing, review or approval of Scientific Validity Reports for EU IVDR submission, or anyone interested in learning more about the SOA section within the SVR.
Who are the Panelists?
Dr. Sarah Chavez, Principal Medical Writer | Criterion Edge
There’s been plenty of discussion on the submission scope of current EU MDR and pending EU IVDR regulatory requirements for medical device manufactures. But what of organizational change management readiness? How should a medical device organization’s different business functions collaborate and align their people, processes, and knowledge to meet these regulatory requirements effectively and efficiently?
Watch the recorded webinar for a behind the scenes look at how one company is managing change within their organization. Dr. Imelda Omana-Zapata, BD Senior Manager Clinical Projects, will provide an overview of how she is planning and coordinating change within her organization to meet upcoming EU IVDR regulatory requirements. Laurie Mitchell, Founder and President of Criterion Edge, will discuss the critical technology and expertise required to meet more rigorous scientific validated submissions to notify bodies.
Key Takeaways:
Key steps involved in helping medical affairs transition to a more rigorous regulatory environments.
How to evaluate talent gaps, team leadership composition, and process challenges of your product portfolio.
Critical systematic literature review technology and experience required to ensure CER and PER submissions are audit-ready and compliant.
Who Should Watch:
Medical Device & Diagnostics Professionals (from small-medium sized to large enterprises)
Who are the Panelists?
Laurie Mitchell, President | Criterion Edge Dr. Imelda Omana-Zapata, Senior Manager, Clinical Projects | BD
In this live 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.
Who are the panelists?
Laurie Mitchell, President | Criterion Edge Caroline Byrd, VP of Regulatory, Quality, and Clinical | Nextern Dr. Krishna Sudhir, Divisional VP, Medical Affairs and Product Performance | Abbott Vascular Sidney Collin, Cofounder and CEO | De Oro Devices
In the first installment of this webinar series, Criterion Edge presents strategies for assessing key components of your CER (or CER template) for possible misalignment with significant and applicable MDR requirements. This practical presentation will help you assess your document through the critical lens of a writer and identify possible gaps for mitigation before submission to regulatory authorities.
In the second installment, we continue to present strategies for assessing key components of your CER for possible misalignment with key EU MDR requirements, examining the clinical data sources, equivalence, and risk/benefit analysis profile sections of the CER.
Finally, in the third presentation we share with you some of the biggest issues we have discovered when starting an MDR CER project based on our experiences with clients both large and small, and we also reveal some of the most successful strategies in addressing these issues, up-front and early.
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.
Are You Reg. Ready? Get your medical affairs team primed to manage new regulatory requirements
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.
Driving Innovation to Success in the Market: Strategic Considerations
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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