Our Test team is involved in our projects from day one —identifying risk and ensuring that our key requirements are test-ready. They provide vital input, working quickly to define the critical points of data in a system, and design protocols to verify and validate them accurately.
Our Verification team develops and executes custom protocols as part of a structured, risk-based process that aligns with FDA and ISO standards to demonstrate that every product requirement is objectively met.
We guide products through FDA and other safety agency regulations by embedding compliance into every stage of development. From early risk analysis to final documentation, we collaborate closely with clients to ensure submission-ready designs that align with all applicable regulations.
Our FDA strategy starts on day one. We identify your product classification, predicate devices, and regulatory pathways, then partner with regulatory experts to tailor pre-submission and submission strategies that streamline approval timelines and reduce or eliminate rework.
Our engineers simulate use environments, conduct accelerated life testing, and identify failure modes early to drive robust design decisions and ensure long-term performance under real-world conditions.
Our user-centered approach centers on studies that reflect actual use scenarios and uncover critical usability risks. Our team facilitates FDA-compliant testing to ensure your product is intuitive, safe, and effective for the intended user population.
