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 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…
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PROCESS OF 510K SUBMISSION 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 that a new medical device is substantially equivalent to a legally marketed predicate device, meaning it has the same intended…
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FDA Requirements for Sterilization Process 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…
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Financial Certification or Disclosure Statement for FDA Financial Certification or Disclosure Statement is one of the sections of 510(k) 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 studies are performed. If performed clinical studies on the device the FDA…
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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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What is UKCA certification? The United Kingdom Conformity Assessed Certification, or UKCA Marking, is only legal in the United Kingdom. It was implemented in response to Brexit and went into effect on January 1, 2021. Manufacturers must adhere to the recommended UK product labeling in order for their items to be sold in Great Britain.…
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Medical Device Cyber Security Plan for Softwarebecome more competent in accessing, analyzing, communicating, and automation to improve the speed and quality of patient care. However, advancements with technological advances arise new risks and concerns. The risk of threats in both network and software is unavoidable through hackers. To assist manufacturers in developing adequate controls, the…
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What is FDA’s Section 506J Notification? Section 506J notification of the FD&C Act requires manufacturers to notify the Secretary of a permanent discontinuance in the manufacture of specific devices or an interruption in the manufacture of certain devices, which leads to disruption in the supply of that device in the United States. This policy is…
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Pre-Clinical Vs Clinical Data Pre-clinical data are the vital testing and safety data collected during the research stage before the clinical trials begin. Tests like in-vitro tests, ex-vivo tests, biological evaluation, simulated use, engineering, performance tests, animal tests, computer modelling, lab tests, stability, shelf life etc. come under pre-clinical tests. Clinical data are used to…
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