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ISO 13485 Consultants

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  ISO 13485 Consultants Medical device organizations must appoint experienced ISO 13485 consultants with knowledge of all risk-class devices. The regulatory requirements in the medical device industry are being constantly reviewed and amended accordingly, with an increasing emphasis on patient safety.   The ISO 13485 Consulting organization must manage and extract value from the vast amounts of structured and unstructured information and data, ensuring their organization stays updated and compliant with regulatory, regional, and local requirements.   The organization should implement effective systems to track and monitor safety and benefit-risk information throughout the life-cycle of its products in line with ISO 13485 requirements. I3CGLOBAL ISO 13485 consultants identify and integrate product-specific regulatory requirements such as MDR, IVDR, or  FDA 510k  during the implementation. This will help later when the organization plans for CE marking or 510k cle...
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510k submission

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  510k Submission Process The 510k submission is the second most common pathway for marketing a medical device in the United States. It demonstrates that the device is substantially equivalent to a legally marketed predicate device that is not subject to premarket approval. A 510k Submission document preparation including device testing, and clinical data consolidation takes up almost 4 to 5 months. Post submissions to the FDA generally take up to 6 months, for closing the review queries.   Our 510k consultants’ careful plan, strategic decisions, and expertise will ensure the early acceptance of the 510k file without RTA or AI and the successful  510k clearance  of the submission. All applicants must submit a soft copy on CD and an e-copy. All foreign manufacturers are requested to have a US Agent for FDA correspondence officially.   Note:  The service of the US Agent is different from the US Agent service for Establishment Registration. Pre and Q 510k Subm...
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