With rapid advancement in science and technology and the growing demands of healthcare, the need for medical devices continues to expand. Regulatory authorities worldwide have established stringent approval frameworks aligned with international standards, where product safety and effectiveness are essential for market authorization.

Under ISO 10993, any medical device that directly or indirectly contacts the human body must undergo a structured biological evaluation. This process may include biocompatibility testing, toxicological risk assessment, and scientific justification for biological safety. When testing is required, studies must be conducted in GLP-certified laboratories to ensure scientific integrity, regulatory compliance, and reduced post-market risk.

Medgaea provides comprehensive biological testing through our TAF- and GLP-certified Life Sciences Institute, led by PhD-level study directors and licensed veterinarians with over a decade of preclinical experience. We uphold rigorous qualification standards and the highest levels of scientific and ethical integrity. Our services include biocompatibility testing for medical devices and biomaterials, as well as regulatory consulting to address development and compliance challenges. Through strategic study design and efficient execution, we help clients accelerate product registration without compromising quality. Our reports have supported successful submissions to the Taiwan FDA, the U.S. FDA, the EU CE marking authority, the China NMPA, and regulatory agencies across Southeast Asia as well. Our professional services are highly regarded and well recognized in the medical device industry.

To ensure a thorough biocompatibility evaluation, we also provide expert support in developing Biological Evaluation Plan (BEP) and Biological Evaluation Report (BER). By adhering to ISO 10993-1 and performing toxicological risk assessments under ISO 10993-17, we deliver scientifically robust and globally compliant evaluations that help clients demonstrate device safety.