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Beschreibung Software as a Medical Device (SaMD) Regulatory Compliance refers to standalone software intended for medical purposes such as diagnosis, monitoring, treatment, or prevention of diseases. Regulatory compliance ensures that SaMD products meet safety, quality, and performance standards set by global health authorities, enabling manufacturers to legally market their solutions.SaMD compliance is governed by international guidelines and regional regulations issued by authorities such as the U.S. Food and Drug Administration, World Health Organization, and the International Medical Device Regulators Forum. Letzte Aktivitäten Verlinkungen |
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