RQM+ Live! #88 — Electric Brains & Regulatory Pains: Accelerate Neurology Innovation, Slash Risk, & Win Approval

Electric Brains & Regulatory Pains: Accelerate Neurology Innovation, Slash Risk, & Win Approval

Neurological devices are rapidly advancing, from AI-driven diagnostics and brain-computer interfaces (BCIs) to transformative implantable therapies for conditions such as Parkinson’s, epilepsy, and paralysis.

But the path to commercialization involves complex regulatory challenges, clinical trial requirements, and unique ethical considerations. This is especially true as innovations increasingly blend hardware with AI-driven software to bridge biological and artificial neural networks.

🧠 So… how do you bring a neurological device to market with losing your mind? (or your regulatory approval)

Join RQM+ experts for an actionable and insightful panel session where you will learn how to:

• Identify High-Potential Innovations: Pinpoint neurological technologies primed for rapid market uptake, including the critical interplay between hardware and AI-based software devices.
• Simplify Regulatory Complexity: Clearly navigate FDA and EU MDR requirements, ensuring compliance without unnecessary delays.
• Manage Ethical and Data Privacy Risks: Tackle head-on the ethical considerations specific to neural devices, including AI integrations and biological data handling.
• Win Clinical Approval: Deploy strategic clinical trial designs and leverage Real-World Evidence (RWE) effectively, ensuring faster and smoother market entry.

This session delivers practical insights to help your organization successfully commercialize innovative neurological products.

Who Should Attend:

• Regulatory affairs professionals
• Clinical trial managers and coordinators
• Product development leaders and engineers
• Quality assurance specialists
• Executives and decision-makers responsible for innovation and commercialization outcomes

Learning Objectives:

• Understand key innovations, especially at the intersection of biological and artificial neural networks.
• Gain clear strategies to streamline FDA and EU regulatory pathways.
• Identify and mitigate ethical and data privacy challenges unique to neurotechnologies.
• Learn actionable methods to design and execute successful neurological clinical trials.

Panelists:

• Allison Komiyama, Ph.D., RAC – Vice President, MedTech Innovations
• Bethany Chung, Ph.D., RAC – Senior Manager, Technical
• Christine Santagate, RAC – Vice President, Lab Services

Moderator:

• Jaishankar Kutty, Ph.D. – Vice President, Regulatory Affairs, Reimbursement, & Market Access

RQM+ certification of attendance available upon request for live attendees.