Our Services
We provide expertise in a wide array of musculoskeletal medical device types.
Our regulatory services include:
Preclinical Study Design
Preclinical Protocol Development
Study Data Analysis
510(k)
Premarket Approval (PMA)
De Novo
Investigational Device Exemption (IDE)
Agency Interaction
FDA Strategy Assessment
Protocol Development
Our services include comprehensive support in writing preclinical animal study protocols that are tailored to meet your specific research and regulatory needs. We work closely with you to determine the most appropriate animal model for your study objectives, ensuring biological and translational relevance. Our team carefully designs study parameters such as sample size calculations, timepoint selection, and control group design to ensure statistical rigor and meaningful outcomes. We help define both in vivo assessments—such as safety, efficacy, and functional performance—and ex vivo outcomes, including histological, molecular, and biomechanical analyses. By integrating scientific expertise with practical study design, we create protocols that are efficient, compliant, and optimized to generate reliable and impactful data.
Data Analysis
We provide comprehensive data analysis services to maximize the value and interpretability of your preclinical studies. Our expertise spans a wide range of modalities, including biomechanical testing to evaluate structural integrity and function, microCT imaging to quantify bone architecture and tissue morphology, and radiographic assessment with standardized scoring for objective evaluation of healing or degeneration. We also perform detailed histomorphometric analyses to capture cellular- and tissue-level changes with precision. To ensure robust conclusions, we apply rigorous statistical analyses tailored to the study design and data type, providing clear, accurate, and publication-ready results. By combining technical expertise with scientific insight, our data analysis services deliver meaningful outcomes that drive decision-making and support regulatory and translational success.
Experience
Our team has extensive experience supporting a wide range of regulatory submissions, including 510(k), PMA, De Novo, and IDE applications. We understand the unique requirements and strategic considerations of each pathway, from demonstrating substantial equivalence for 510(k) clearances to generating the robust safety and effectiveness data required for PMA approvals. For novel technologies, we guide clients through the De Novo process, helping to establish new device classifications and regulatory pathways. We also have expertise in preparing Investigational Device Exemption (IDE) submissions, enabling first-in-human studies by ensuring that preclinical evidence, risk assessments, and study protocols meet FDA expectations. By combining regulatory knowledge with deep preclinical expertise, we help streamline submissions, reduce review cycles, and position your device for successful clearance or approval.
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