Steps for Getting CE Marking

  As the US Food and Drug Administration’s medical device and IVD review process becomes more complicated, partnering with an experienced USFDA Regulatory Consultants can make a significant difference in your authorization and compliance efforts & process. If your goal is to implement a quality management system that complies with the FDA Quality System Regulation (QSR) or obtain 510(k) premarket clearance, skilled USFDA Regulatory Consultants can guide you through all US regulatory requirements. Medical Device Manufacturers require USFDA Approvals to sell their products in USA. USFDA differentiates product approvals in Class I, II &III depending upon the risk associated. The submissions include self-certification, 510(k) and PMA depending upon the class of the product. IZiel implements an Outcome-Based Delivery Model to provide complete solution from developing engineering documentation to receiving USFDA Approvals & establishment registrations th...

  Clinical Evaluation Report (CER) makes a strong case for your device and its intended use backed by impactful scientific evidence. The aim of a CER is to reduce the risk that the users and patients are exposed to when using a medical device. Clinical evaluation is an essential prerequisite for risk management. It justifies the assumptions made in the risk management file, with respect to the benefits and thus the acceptance of a certain risk-benefit ratio. MEDDEV 2.7/1 Rev 4 of the clinical guidance document was released in June 16 and is aligned more with the European Medical Devices Regulation. The guidelines are more detailed and explicit and help manufacturers to conduct systematic clinical evaluations in a more robust manner so as to demonstrate the efficacy, safety & performance of their device. The complexity of a Clinical Evaluation Report can vary significantly, but the result should be the same. The performing report should be good enough to read and understood...

The manufacture of safe and high- quality pharmaceutical products require good manufacturing processes. This is the thing of Process Validation, i.e., icing pharmaceutical products constantly meet quality norms and prospects. The way to achieve this is through the Three Stages of Process Validation for medical devices. Why is Process Validation Testing Important? To ensure customer satisfaction To be confident about the product To fulfil the client’s requirement until the optimum capacity Software acceptance from the end-user Phases of Process Validation Testing Process – ·          Define Requirements ·          Team Selection ·          Maintaining Documentation ·          Validation Report ·          Incorporation of changes Validation testin...

  What is Process Validation? The FDA defines process validation as, “the collection and evaluation of data, from the process design stage through marketable product, which establishes scientific substantiation that a process is able of constantly delivering quality product”. A foundational tenet of this FDA guidance document is the lifecycle conception. The lifecycle approach is concerned not only with the original drug development processes; but also, the establishment of marketable manufacturing and routine marketable product until discontinuation of the product. Process Validation is conducted to ensure consistent delivery of quality products meeting its predetermined specifications/requirements and quality characteristics. This enables to ensure the complete safety & efficacy of medical device. IZiel works with your team to assist you to complete all the following process validation activities for your medical devices . ·       ...

  FDA 510k Consultants or USFDA Consulting Firms can help you navigate the complete process for any medical device Class I, Class II, and Class III by completely understanding the device and by relating any possible risks. Good and educated specialized experts assure briskly 510k clearance.   Still, please read below to understand how we support customers to prepare and submit the 510k File briskly with lower chance of entering an original “Refuse to Accept” (RTA) hold or an “Additional Information” (AI) request from the FDA, If you're a manufacturer or a specification inventor.  Activities of USFDA 510k Consultants or USFDA Consulting Firms Identify Device Class, product code, and Regulation Appropriate Predicate device Identification Identify Appropriate guidance and control documents Choosing an appropriate type* of US FDA 510k submission Prepare Indication for Use statement Declaration of Conformity Identification ...