The CE marking Self Certification plays a key role in showing if products are good to go for sale in the European Economic Area (EEA). But not every product needs a third party to give it the thumbs up. To some extent, manufacturers can go for products Medical Device CE marking when engaging in production.…
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One of the most important standards to meet while conducting business in the European market is the CE Marking Certification. But of course, one might find himself or herself wondering what CE Marking Certification all entails. In what ways does it affect manufacturers and the community of consumers? What this blog seeks to do is…
DetailsFDA 510k Database Navigating the Essential Resource for Medical Device Approval: The FDA 510k Database Subsequently, regulations governing the deal of medical devices are, for the most part, understandable to manufacturers. The FDA 510(k) Database is valuable for a broader look wherein one can get all the data related to the clearance status of…
DetailsSpecial 510(k) Guidance – Efficiency And Precision In Medical Device Clearance Particularly in medical device regulation, manufacturers must navigate the approval processes with precision and speed. The Special 510(k) guidance of the FDA is one such accelerated technique where it is made sure that changes in the devices are authorized quickly so that they can…
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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…
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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),…
DetailsSURGICAL 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…
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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…
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Financial Certification or Disclosure Statement is one of the sections of FDA 510k submission that mentions a single statement like “This section is not applicable as no clinical studies were performed to test this device” if no clinical evaluation studies are performed. If performed clinical studies on the device the FDA has provided the two forms…
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Differences between Standards, Recognized consensus standards, and Guidance Standards Recognized consensus standards Guidance A standard is a repeatable, harmonized, agreed, and documented way of doing something. It is a database that provides the most up-to-date list of voluntary consensus standards to which the FDA will accept a Declaration of Conformity. Guidance documents represent FDA’s current thinking…
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