The Safe Medical Devices Act (SMDA) of 1990 was enacted to strengthen the regulation and post-market surveillance of medical devices in the United States.
Corrective and Preventive Actions (CAPA) form the backbone of any quality management system (QMS), ensuring continuous improvement and compliance with industry regulations.
The Medical Device User Fee and Modernization Act (MDUFMA) is a crucial piece of legislation that governs how the U.S. Food and Drug Administration (FDA) regulates medical devices.
Premarket Approval (PMA) is a cornerstone of the U.S. Food and Drug Administration’s (FDA) strategy to ensure that high-risk medical devices meet stringent standards for safety and effectiveness before reaching the market.
Ground Fault Circuit Interrupters (GFCIs) are a crucial component in electrical safety, primarily used in residential and industrial electrical systems.
Printed Circuit Boards (PCBs) are the foundation of modern electronic devices, providing the necessary interconnections for components to function efficiently.
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