Are you navigating the right evidence and strategy to advance your neurology medical device? Developing neurological medical devices requires early alignment across regulatory strategy, preclinical and clinical evidence to avoid costly delays and rework. In this webinar, NAMSA regulatory, preclinical, and clinical experts specializing in neurology will share practical considerations and real‑world insights to help device companies anticipate challenges and make informed decisions throughout the development process. Attendees will gain a clearer understanding of how to align requirements and expectations across the product lifecycle.
Key Learning Objectives:
- Regulatory considerations for neurological devices, including strategy and FDA expectations
- Preclinical considerations for neurological devices, including study design and model selection.
- Clinical considerations for neurological devices, including site logistics and recruitment strategies
Speakers
Monica R. Montañez, MS, RAC, CQA
Principal Strategy Consultant, Regulatory
Monica Montañez has over 25 years of experience in the medical device industry, working with a broad range of medical device technologies and organizations. Monica began her medical device career with Millar Instruments and then with Cyberonics (now Liva Nova), CONMED, Generic Medical Devices, Inc, Cochlear and before joining Medtronic in 2010. With NAMSA, Monica then moved into consultancy where the focus of her work has always been working with manufacturers with complex submissions for novel devices. She is the in-house expert for regulatory software as a medical device and artificial Intelligence, machine learning. Monica also holds a Master of Science in Regulatory Science from the University of Southern California School of Pharmacy and a Regulatory Affairs Certification from the Regulatory Affairs Professional Society (RAPS).
Principal Strategy Consultant, Preclinical
Dr. Jack Risdahl has over 30 years of experience in medical product development and testing. Dr. Risdahl has both Doctor of Veterinary Medicine (DVM) and Doctor of Philosophy (Ph.D.) degrees, and began his career in academia at the Medical and Veterinary Schools at the University of Minnesota. Following, he served in a Global Director role at Baxter while also holding a faculty position at the Mayo Clinic.
Prior to joining NAMSA in 2012 through acquisition, Dr. Risdahl was an entrepreneur, co-owner and managing partner of the Integra Group. While at NAMSA, Jack was the Director of Preclinical and Functional Studies with global oversite before joining the Global Strategy Consulting Group in 2017. His expertise in preclinical studies and safety evaluations allows him to work with innovative medical device companies looking to accelerate the development of their technology, and to also address regulatory agency expectations and responses to those studies. As a former entrepreneur, he is also able to understand and assist in product development strategies for accelerating product development testing that meet specific business goals. He has a broad experience across the medical device spectrum of products for devices, biologics and combination products including but not limited to regenerative medicine, cell therapy and transplantation, neurostimulation and cardiovascular devices.
Manager, Clinical Study Management
Amanda Slavsky has been in the clinical research industry for over 11 years, with 9 years focused on medical devices. Amanda has extensive experience focused on neurology (CNS, movement disorders) and neurosurgery (stroke, spine, brain tumors, aneurysms) along with ophthalmology, peripheral vascular, and more. She has led complex, multicenter trials from early-phase to post-market, ensuring global compliance with FDA, ICH-GCP, and ISO 14155 standards. She has provided strategic leadership and guidance throughout multiple FDA BIMO audits and site preparations with favorable outcomes. Prior to joining NAMSA, Amanda was the Executive Director of a nonprofit research organization focused on promoting research and training the next generation of neurosurgeons, neurologists, and neuroscientists. Additionally, she has worked with academic institutions such as the University of Tennessee Health Science Center and the University of California, San Francisco, supporting global trials and regulatory interactions.
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This is a free educational webinar.
