Demonstration of Sufficient Evidence and Regulatory Strategy Alignment in the Clinical Evaluation Process
In the first part of our webinar series, we discussed Legacy Devices, WET devices, and devices exempt from Clinical Investigations under Article 61, along with the need for data sufficiency and how significant changes impact the route to conformity. In this webinar, our medical regulatory experts, Dr. Sarah Chavez and Stacie Beecham, discuss the concept of data sufficiency and give you strategies for addressing limited clinical and performance data. We also discuss adjusting the Clinical Evaluation Plan to align with the regulatory strategy.
How do you determine which content applies to each classification? How do you address data insufficiency for a WET or Legacy device? We answer these questions and outline how to ensure your regulatory strategy will adequately support the clinical evaluation specific to your device.
Click here to watch the recording of this webinar.
Who should register for this webinar?
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.
How to Empower Data-Driven Decisions in Your Organization
Every day, pharma and medical device companies need data from Systematic Literature Reviews (SLRs) to inform, direct, and help drive their internal processes and decisions. Of course, to comply with global regulatory requirements, clinical literature is also required. 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.
Download our free white paper, Systematic Literature Review: How to Empower Data-Driven Decisions in Your Organization to read more on this topic.
You can also watch our webinar on this topic.
Our President Laurie Mitchell joins Jennifer Tetzlaff, Research Product Specialist with Evidence Partners, to talk to you about the following points:
- Examples of how the use of published data can support regulatory expectations
- When to conduct a systematic literature review
- Best practices for conducting a methodologically-sound SLR
- Use of available tools and technology