For Immediate Release / July 23, 2024
Contact: Shawn M. Schmitt / shawn@essenvia.com / +1 305-240-9339
Blue-Ribbon Expert Industry Panel Talks Regulation vs. Innovation and More at Essenvia Webinar
LOS ANGELES – When medical device regulation collides with MedTech innovation, sparks can fly. A manufacturer that is working to develop a novel disease-curing medical product could suddenly find itself behind the compliance 8 ball, spending unanticipated resources, including time and money.
What can device companies do to minimize fallout when that inevitably happens?
What are some potential hurdles that manufacturers should be ready to jump as regulators in the US and EU change the rules around medical device manufacturing with new quality systems regs?
What are key components that should be part of every responsible manufacturer’s overarching regulatory strategy?
Get the answers to these questions and much more when a panel of longtime MedTech industry professionals gather for the Essenvia roundtable webinar:
“Shaping the Future of MedTech: Insights at the Crossroads of Regulation and Innovation”
When: July 31, 2024 @ 2 PM EST
Cost: FREE
Register: https://us02web.zoom.us/webinar/register/8317216742249/WN_U61NrZVbT3aXD4JOW_KK0w
Panelists:
Dr. Jay Vaishnav
Director of Regulatory, Canon Medical Informatics
Dr. Jay Vaishnav’s 20-plus year career in regulatory and medical affairs, scientific research, and education has seen her contribute to the commercialization of hundreds of software and hardware devices in the medical imaging and radiation therapy spaces. A decade of service at the US Food and Drug Administration (FDA) and the National Institute of Standards and Technology (NIST) led to regulatory affairs director roles at Canon Medical Informatics and at RefleXion Medical. She has written numerous scientific publications and is co-editor of “From X Rays to AI: Navigating US Regulations in Radiological Health” and the forthcoming “Fundamentals of Medical Device Regulations: A Global Perspective.” Dr. Vaishnav is a fellow of the Regulatory Affairs Professional Society (RAPS) and holds a doctorate in physics from Harvard University.
Dr. Dhriti Roy
VP of Regulatory Affairs Transformation, Essenvia
Dr. Dhriti Roy has more than 20 years of experience as a regulatory affairs executive and digital transformation expert across various industries including medical devices, in vitro diagnostics, pharmaceuticals, biologics, and consumer products. She has demonstrated successful leadership and expertise in the execution of quality, regulatory, and clinical strategies for market-leading companies like Abbott, Medtronic, Zoll, Danahar, and Labcorp, as well as early-stage organizations. She assists manufacturers in sending IDEs, PMAs, and 510(k)s to the FDA. Dr. Roy specializes in FDA regulatory compliance, EU MDR and IVDR transition, and SaMD and SiMD regulations. She is also a leading scientist and has contributed to highly ranked scientific research publications. As faculty at Oxford University, she mentors Innovations and market access in the medical technologies sector.
Steve Silverman
President, The Silverman Group
Steve Silverman is president of The Silverman Group, a medical products regulatory, strategy, and policy issues consultancy. He previously was technology and regulatory affairs VP for AdvaMed and a senior expert for McKinsey & Co. Silverman’s professional experience includes almost two decades in federal experience at the US Food and Drug Administration. While at the FDA he directed the Office of Compliance for the agency’s medical device center where he led product quality initiatives and guided the center’s reorganization. Silverman was also assistant director of the Office of Compliance for the FDA’s drugs center. Further, he was associate chief counsel for the agency, where he led enforcement actions against drug and device companies. Early on in his career he held positions with the US Department of Justice (DOJ) and the Federal Trade Commission (FTC).
Dr. Carrie Kuehn
Principal Consultant & Founder, Evergreen Strategic Consulting
Dr. Carrie Kuehn is head of regulatory at Liquet Medical Inc. and has more than 25 years of experience in research epidemiology, medical devices, regulatory and clinical affairs, and patient-focused policy. She launched Evergreen Strategic Consulting in 2019 and has been published in the areas of epidemiology, regulatory affairs, and patient engagement policy. Dr. Kuehn is faculty in the RAQA graduate program at Philadelphia’s Temple University and the Regulatory Affairs Graduate Program at the Hong Kong University of Science and Technology.
More Info:
“The conversation around MedTech regulation and medical device innovation is one that can’t be condensed into one short webinar, but we want to be the one to get the discussion rolling on such a topic of importance to MedTech regulatory professionals,” says Essenvia CEO Soumya Mahapatra. “A diverse, highly skilled discussion like this shouldn’t be missed – and that everyone can learn from our panelists’ years of experience is great for industry.”
Panelists will dissect and discuss challenges manufacturers face as they work to comply with rules and regulations. Key topics will include generative artificial intelligence (GenAI), digital health, the EU’s Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR), the US Food and Drug Administration’s Quality Management System Regulation (QMSR), and much more.
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Founded in 2018, Essenvia is a MedTech RIM platform that gives you the tools you need to manage regulatory workflows across the total product lifecycle, accelerate global market access, and generate exponential business value. Learn more about what Essenvia can do for your MedTech company at Essenvia.com.