Medical Device Efficacy Testing

The development of innovative medical devices requires thorough clinical evaluation to ensure their safety and effectiveness before they reach patients. ABS Clinical Solutions provides comprehensive clinical testing services for a wide array of medical devices, from diagnostics to surgical instruments and implantable technologies. Our team understands the unique regulatory pathways and clinical considerations for medical devices (e.g., ISO 14155, FDA 21 CFR Part 812). We design and execute clinical investigations that meet specific regulatory requirements for market approval. We offer expertise in areas such as usability studies, performance evaluations, post-market clinical follow-up (PMCF) studies, and registries. Our commitment is to provide robust data that demonstrates the clinical utility and safety profile of your medical device, supporting successful regulatory submissions and market adoption.