IZiel adopts an analytical mindset thus enabling us to root out all possible non-conformances in a regulatory submission. IZiel works in collaboration with your team to develop the complete Design History File (DHF) including requirements management, risk management, process validations and software validations using robust design controls process and quality system procedures. Thereafter, IZiel team works with their regulatory team in USA to complete the submissions (510k or PMA) for USFDA Approvals.

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