Grow your Neurology Market Share with Strategic M&A and Portfolio Support
Our integrated technical, clinical, and regulatory assessments ensure you are making sound strategic investments with comprehensive due diligence de-risking acquisitions or enable startups value positioning.
Navigating the Complex and Evolving Regulatory Landscapes
A thorough gap analysis will lead to effective device development and a strategic submission and market strategy. With extensive experience as a direct liaison with the FDA or a Notified Body, we provide submission support and execution to ensure you meet every milestone with confidence.
Regulatory Services
From User Insight to Optimized Procedure
Our process begins with our Research and Strategy team immersing themselves in the clinical environment to understand critical needs, usability concerns, and opportunities that guide effective development. We then bring those insights into our state-of-the-art preclinical facilities, where our technical experts use advanced imaging like CT, MRI, and 3D fluoroscopy with realistic surgical models to refine and optimize the procedural workflow for real-world success.
A Proven Infrastructure for Your Neurology Study
Our research infrastructure is purpose-built to support your neurological medical device through every stage of development. We are a core specialty in both non-GLP and GLP studies for neurosurgery and neuromodulation, leveraging large animal models, advanced electrophysiology for neural monitoring, and in-depth pathology evaluation to generate the reliable data required for a successful regulatory submission.
Expert Clinical Research in Neurology for Confident Outcomes
We provide unparalleled value in designing and managing trials for neurological medical devices, including combination devices. Our deep expertise in clinical research for neurology ensures your trial is structured for success, generating the high-quality evidence needed for regulatory approval and market adoption.
Trial Design
Quality at the Core of Every High-Risk Device
Neurological devices have high-risk classifications and provide valuable, life-changing impacts for patients. We ensure quality is the foundation of your device by integrating our teams and services to define robust design inputs, resulting in a reliable and safe product ready for market release.
Bring your Neurological Medical Device to Market Successfully
Our integrated, cross-functional teams translate user and market needs into a successful commercial product. We define opportunities with actionable insights, use human-centered design experts to refine concepts, and integrate supply chain and human factors teams from early design through validation to deliver a verified and market-ready device.
