Medical Device Assessment

Medical device assessment is the process of evaluating a medical product to ensure it is safe, effective, and suitable for use. This involves reviewing clinical data, manufacturing quality, and risk considerations. Regulatory agencies, like the FDA or EMA, analyze evidence to determine whether the device performs as intended without causing undue harm. The assessment covers design, materials, and performance in real-world conditions, helping healthcare providers and patients trust that the device meets strict standards before it is made available on the market.