Medical Device Stability Testing Medical Device Stability Testing is conducted to determine the environmental effects such as temperature humidity, light, moisture, pH, agitation, gravity on product strength, quality, and purity. Such testing’s are conducted in the life sciences, chemical, medical devices, IVDs, pharmaceuticals, and food industries. Stability Testing provide supporting evidence to establish product storage…
RELATION BETWEEN CLINICAL EVALUATION AND RISK MANAGEMENT Relation between Clinical evaluation and risk management are closely intertwined in the context of medical devices. Clinical evaluation is the process of collecting clinical data and evidence to assess the safety and performance of a medical device throughout its lifecycle. This evaluation includes the review of existing…
SURGICAL SUTURES 510(k)PROCESS The 510(k)-submission process is a premarket notification process required by the United States Food and Drug Administration (FDA) for certain medical devices. The purpose of the process is to demonstrate how surgical sutures are substantially equivalent to a legally marketed predicate device, meaning it has the same intended use and…
[A] Non-Active Medical Device Labelling Information on the EU MDR Medical Device Labelling Requirements Name or trade name of the device. Necessary details for a user to identify the device, the contents of the packaging, and the intended purpose of the device. The name, registered trade name or registered trademark, and the address of its…