We provide services including safety evaluation of pharmaceutical injectables, genotoxicity safety evaluation of drugs, pharmacokinetic studies, pharmacodynamic studies, respiratory toxicology studies, reproductive toxicology studies, bioequivalence assessment of generic drugs, safety and efficacy evaluation of medical devices, non-clinical and clinical safety evaluation of veterinary drugs, drug testing, packaging material testing, and more for pharmaceutical and medical device R&D institutions, research institutes, and pharmaceutical companies.

Medical devices


Evaluation of Medical Device Safety and Effectiveness

Medical devices refer to instruments, equipment, apparatuses, in vitro diagnostic reagents and calibrators, materials, and other similar or related articles that are intended for direct or indirect use on the human body, including any necessary computer software. Medical devices include medical equipment and medical consumables. The utility is primarily obtained through physical means, rather than through pharmacological, immunological, or metabolic mechanisms—or even if these mechanisms are involved, they play only a supporting role.

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