USFDA Consulting for Medical Device

 As we all know, some USFDA regulations are extremely specific and special for medical devices and IVD which are supposed to be sold in the USA.

So even for Global manufacturers, approval in many countries and selling them would not just automatically give approval for sale in the USA.

Recommending USFDA consulting to medical device and IVD manufacturers may look sales gimmick so let us first look what are the requirement and corresponding regulations or documentation.

510K submission, IDE (investigation device exemption) submission or clinical trials, for Classification query and resolution, if the manufacturer is outside then effective representation, Audits, and audits of suppliers, form 483, and warning letter resolution, apart from other general guidance on day-to-day affairs like pre-submission meeting, 21 CFR part 820 understanding.

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, the IZiel team works with their regulatory team in the USA to complete the submissions (510k or PMA) for USFDA Approvals.



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