Demonstration of Sufficient Evidence & Regulatory Strategy Alignment in Clinical Evaluation Process



Published
#WellEstablishedTechnology #LegacyDevice #ClinicalData #GSPR #ClinicalEvaluationPlan #ClinicalEvaluationReport


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, we will discuss the concept of data sufficiency and give you strategies for addressing limited clinical and performance data. We will 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.


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Who should watch this webinar?
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 anyone interested in learning more about these requirements.


Speakers
Sarah Chavez, PhD


Dr. Sarah Chavez has worked on medical and regulatory writing for three years and has a BS in Biochemistry and a PhD in Molecular and Cellular Biology, with 25 years of laboratory bench experience. She has a strong understanding of a wide range of laboratory techniques, and has taught Genetics, General Biology, Cancer Immunology, and Global Health at the University level for the past 15 years. Prior to joining Criterion Edge, Sarah had extensive scientific writing experience in an academic environment, having written many large institutional research grants, regulatory documents, clinical trials protocols, book chapters, and manuscripts, as well as textbook chapters and educational materials for several large textbook publishers. Sarah’s strong background in basic research and her extensive experience with regulatory writing will allow her to assist companies with IVDR readiness as part of the Criterion Edge team.


Stacie Beecham


Stacie Beecham is a Principal Medical Writer with Criterion Edge. Stacie has a BS in Biology and a MS in Human Physiology, with extensive experience in regulatory writing and 10 years of experience in international regulatory affairs. Stacie was a medical researcher prior to entering the regulatory space, where she worked with physicians, scientists, and hospital pharmacists at Mayo Clinic in Minnesota. Stacie's expertise in regulatory affairs, submission writing, clinical research, and regulatory consulting for medical device, biopharma, and biotech makes her a valuable asset to the Criterion Edge team.
Category
Health
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