Category Archives: Preclinical Research

A medical device can function as intended and still create unacceptable biological risks when it contacts the body. That is why ISO 10993 biocompatibility testing is an important part of medical device development, risk management, and regulatory planning. ISO 10993 is not a universal checklist assigning the same tests to every product. It is a […]

Some studies explore feasibility, improve a prototype, or confirm surgical workflow. Others generate formal data for regulatory review. Understanding GLP vs non-GLP preclinical studies helps teams choose the right path. The right approach depends on device stage, study goals, risk, timeline, budget, and regulatory intent. An early concept may not need the same study structure […]

Choosing the right preclinical research partner is one of the most important decisions a MedTech company can make before moving a device, material, implant, instrument, or therapeutic technology closer to regulatory review and clinical use. Preclinical research is not just about running a study. It is about asking the right questions, selecting the right model, […]

The success of a medical device depends on more than innovative design—it requires rigorous, reliable, and clinically relevant preclinical testing. As regulatory expectations rise and technologies become more complex, MedTech companies need research partners that can deliver precision, reproducibility, and translational confidence.  IBEX Preclinical Research has emerged as a leader in this space by redefining […]