Within the medical device development industry, preclinical studies are on the rise as medical technologies become progressively complex. While biocompatibility testing is required for novel devices, biological effects can increasingly be addressed by pairing materials characterization with risk assessment activities. However, the assessment of critical preclinical endpoints are often only achievable through the utilization of in vivo studies, and preclinical studies are typically required to address more complex effects such as implantability, usability, and overall safety. Therefore, it is critical that global medical device manufacturers understand how to effectively develop and design customized studies to achieve successful preclinical study outcomes.
This NAMSA webinar, presented by Dr. Joseph Carraway (NAMSA’s Scientific Director of Laboratory Services), will provide information that draws upon the U.S. Food & Drug Administration’s (FDA) Guidance Document on “General Considerations for Animal Studies for Medical Devices” (issued in 2015), and will provide a better understanding of:
Time will also be allotted for Q&A.
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About the Presenter
Dr. Joseph Carraway has worked for NAMSA since 1996 and currently serves as Scientific Director of Laboratory Services. He holds a Doctorate in Veterinary Medicine and an MS in Laboratory Animal Medicine, and possesses over 36 years’ experience in clinical medicine and surgery, biomedical science and testing procedures.
Dr. Carraway is actively involved in designing and conducting various in vivo studies to demonstrate “proof of concept,” efficacy, biocompatibility, and safety for medical devices and combination productions. He works closely with Sponsors and the FDA to design unique preclinical studies to meet research and regulatory requirements. His knowledge of in vivo models, research methods and regulatory requirements allows him to help develop studies that efficiently meet Sponsor needs and enable regulatory approval.
Additionally, Dr. Carraway has participated in numerous FDA meetings to discuss submission requirements, preclinical study design and interpretation of results. He has authored various publications on preclinical testing requirements for medical devices, and has delivered various presentations on preclinical topics, ISO requirements for surgical implantation and genotoxicity studies, and ISO certification in in vivo research facilities.
Dr. Carraway is actively involved in ISO committee TC194, which is responsible for establishing the global testing guidelines and requirements for medical devices, ISO 10993: Biological Evaluation Medical Devices. Within the U.S. Technical Advisory Group to TC194, he is a designated expert for Part 2 (Animal Welfare), Part 6 (Implantation), Part 11 (Systemic Toxicity) and Part 12 (Sample Preparation).