Bridging the Gaps: Determining When Clinical Data is Necessary to Demonstrate Conformity with GSPRs

#clinicalevaluation #clinicaldata #legacydevice #wellestablishedtechnology #medicaldevice
What do I do if there is no data for my device? This is a concern we hear quite often from clients. MDR states that device groups may not require clinical investigations if sufficient clinical evidence exists, and the device meets specific criteria. In this webinar, we will discuss the concept of data sufficiency. Specifically, we will explain the differences between a well-established technology and a legacy device as defined by MDR and discuss strategies from both a regulatory and writer's perspective.
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During this presentation, we …
• Discuss MDR definitions of legacy, well-established technology, and devices covered under MDR Article 52 (Class IIb) or Article 61(Class III)
• Review alternate routes to conformity that may not require clinical investigations
• Describe strategies from both a regulatory and writer’s perspective
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.