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 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 clinical literature, clinical investigations, post-market clinical data (PMS),…
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…
FDA Sterilization Guidance Medical Device Sterilization: To avoid disease transmission linked with the use of an item, sterilization destroys all microorganisms on its surface or in a fluid. Either a physical or chemical process that destroys or removes all microbial life in a specific area, including spores. Sterility: the reduction of anticipated levels of…