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Posted by Prajakta on April 25, 2024 at 8:16am 0 Comments 0 Likes
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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 thereafter. Our teams from USA & India collaborate to develop a Cost-Effective Model to complete USFDA Approvals for customers in USA, Europe and Asia.
https://iziel.com/usfda-consultants-medical-device/
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