The top consultants have relevant experience within the industry, knowledge of the right regulatory frameworks, and proven experience working on similar projects. Regardless of whether you’re trying to develop a regulatory strategy, prepare for a submission or respond to the FDA, working with a consultant who’s succeeded in similar situations can increase your chances of a favorable outcome.
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.

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 and Orthopedic products.