Optimize USFDA Approval Process

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 Consultants working for medical devices.

 

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Regulatory Mapping in US FDA

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

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 (510(k) or PMA) and resolve queries, if any, from USFDA.

Upon completion of Engineering & QMS Documentation, the regulatory team of IZiel conducts the predicate device search, comparative analysis and ensure all the necessary standards are complied with. Thereafter, IZiel team initiate the writing of 510 (k) / PMA, which is verified and approved by our US Regulatory Consultants.

 

Our highly experienced US regulatory consultants include Ex-FDA Auditors, have conducted 3500 + reviews and approvals and have experience with Class I, II & III devices in Cardiology, Neurology, Image Diagnostics, Surgical, Wound Dressing & Hospital Equipments.