Evaluation and Vetting of Medical Devices
We offer thorough evaluation and vetting services for medical devices at every stage of development, from pre-prototype (physiologic response/research) through the final version (GLP), including post-commercialization iterations. Beginning from the initial ideation phase, we assist in the translation of physiologic theories and conceptual designs into tangible prototypes. Through our experience, we can help identify potential areas for improvement and optimization, laying the groundwork for a successful development trajectory.
Data Generation Strategies
We understand the critical role of data in driving informed decision-making and securing necessary funding for product development. Our data generation strategies are meticulously designed to capture relevant data points that effectively assist with fundraising or go/no-go decision making. By employing a strategic approach to study design, data collection, analysis, and interpretation, we enable you to make well-informed decisions, fostering confidence among stakeholders and investors.
Preclinical Study Design Development and Review
Our team specializes in the development and review of robust preclinical study designs, critical for establishing the performance, safety and efficacy of medical devices. Through meticulous study design development, we can lay the groundwork for comprehensive data collection and analysis. Our rigorous review process aims to ensure the integrity and reliability of each of your preclinical studies, providing the necessary foundation for a successful regulatory submission.
Multifunctional/Multidisciplinary Strategy Development and Execution
With a focus on comprehensive and cohesive development, we strive to integrate multifunctional and multidisciplinary strategies that encompass R&D, regulatory, clinical, and quality perspectives. Our collaborative approach can ensure that every aspect of your medical device’s development is meticulously aligned across your entire team. By fostering cross-functional communication and collaboration, we can help streamline your development process, mitigating risks and maximizing the potential for a successful development process and regulatory submission.