What is an FDA 510k consultant?

 

FDA 510k Consultants or USFDA Consulting Firms can help you navigate the complete process for any medical device Class I, Class II, and Class III by completely understanding the device and by relating any possible risks. Good and educated specialized experts assure briskly 510k clearance.

 Still, please read below to understand how we support customers to prepare and submit the 510k File briskly with lower chance of entering an original “Refuse to Accept” (RTA) hold or an “Additional Information” (AI) request from the FDA, If you're a manufacturer or a specification inventor.

 Activities of USFDA 510k Consultants or USFDA Consulting Firms

  • Identify Device Class, product code, and Regulation
  • Appropriate Predicate device Identification
  • Identify Appropriate guidance and control documents
  • Choosing an appropriate type* of US FDA 510k submission
  • Prepare Indication for Use statement
  • Declaration of Conformity
  • Identification of Biocompatibility tests
  • Identification of Performance test
  • Sampling Plan
  • Requirements for stability studies
  • Review of the Risk management firms

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.

Following illustration would help you to understand the requirements of USFDA Approvals –



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