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| Name | Critical Concepts: Deep Dive into MDR and IVDR Device Classification and Data Collection Strategies |
| Video Uploader | Video From Criterion Edge |
| Upload Date | This Video Uploaded At 03-11-2022 02:05:48 |
| Video Discription | #clinicalevaluation #clinicaldata #CER #MDR #regulatoryaffairs #legacydevices #IVDR #mdcg What is this webinar about? 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. In this "Critical Concepts" webinar, we 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" provides insights into the potential impact of risk-based classifications on your data collection strategies to support data sufficiency in the CER and PER. Have more questions? Reach out to us at info@criterionedge.com. Want to be notified of future webinar postings? Click here: https://go.criterionedge.com/webinar_notifications Who should watch? 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 legacy devices. 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. z_SBfXacPQk |
| Category | Science & Technology |
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