USFDA Regulatory Consultants

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 and submissions may be done through USFDA Regulatory Consultants working for medical devices.

As per the role of USFDA Regulatory Consultants, IZiel works with medical device manufacturers to complete engineering documentation, QMS implementation and make USFDA submissions to ensure all non-conformances are resolved.

 

 

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Regulatory Mapping in US FDA

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USFDA Regulatory Consultants – IZiel Approach

We at IZiel, approach any regulatory concern with an risk based and analytical approach thus enabling us to root out all possible non-conformances in a regulatory submission.

Regulatory Consulting team at 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 regulatory team from USA & India collaborate to complete the submissions (510(k) or PMA) and resolve queries, if any, from USFDA.

Being one of the most prominent USFDA regulatory consultants, IZiel works with an Outcome-Based Delivery Model which enables companies to get USFDA Approvals in shorter timelines and most cost effective.