AmCad BioMed has been awarded the first EU MDR intelligent medical device software certification in Taiwan

AmCad BioMed has successfully achieved EU MDR certification for its entire product line, becoming the first certified intelligent medical device software company in Taiwan. This accomplishment demonstrates the effectiveness and safety of AmCad BioMed's products, meeting the EU's highest regulatory standards.

As the first in Taiwan to apply for MDR certification for intelligent medical device software, AmCad BioMed's swift completion of the process showcases exceptional efficiency. This achievement is attributable to seamless collaboration across regulatory, R&D, and human resources departments.

The EU's MDR, replacing the current MDD, imposes stricter requirements to enhance medical device quality. It mandates post-market surveillance and clinical follow-up studies, particularly challenging due to the one-year deadline for gathering evidence. As of late 2022, only less than 2,000 out of 8,000+ applications have met these stringent criteria.

AmCad BioMed, already possessing MDD certification, has remarkably attained MDR compliance within a year for its AmCAD-UT, AmCAD-UO, and AmCAD-US lines. This accomplishment underscores AmCad BioMed's leading position in AI-powered ultrasound technology.

Source: https://money.udn.com/money/story/5612/7587908