Join Lisa Ferrara, Ph.D., Technical Director for Element’s Medical Device Consulting and Regulatory Division, for a live webinar hosted by Medical Product Outsourcing (MPO). The webinar will provide a basic overview of the FDA's regulatory process for regulating medical devices. The regulatory pathways for multiple classifications of medical devices will be presented, along with an overview of the process to take a new device from concept to commercialization and the associated challenges.
Why should I attend?
Dr. Lisa Ferrara will guide attendees through the FDA regulatory process for regulating medical devices. Her presentation will include:
- An overview of the FDA regulation for medical devices
- Regulatory pathways and challenges
- Market submissions and classifications
- Understanding the 510K process
Register with the link below to secure your spot.
Lisa Ferrara, Ph.D., is the Technical Director for the Medical Device Consulting and Regulatory Division of Element. Academically, she held a joint appointment for the Departments of Neurosurgery and Orthopedic Surgery at The Cleveland Clinic Foundation, where she founded the Spine Research Laboratory and served as the director.
During her 25 years of academic research, she had written more than 60 journal publications, 26 book chapters, had been granted multiple patents, and given over 70 invited lectures on innovative technologies, biomaterials, nanotechnology and nanomedicine, musculoskeletal and spinal biomechanics, biomechanics of brain injury, additive manufacturing, and regulatory strategies.
She serves on multiple healthcare advisory boards and was an original member of the Southeastern Regional Biotechnology Advisory Board for North Carolina. She currently serves on the editorial staff of multiple orthopedic and spine medical journals and was highlighted in the National Association of Distinguished Professionals as one of the top 100 industry experts in medical devices.
Medical Device Regulatory Services
Element’s regulatory advisors have 30 years of domestic and international regulatory consulting experience, specializing in handling the most complex challenges and partnering with you on the path to submission.
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