How USFDA Consulting Firms Help Companies Navigate Regulatory Challenges

Selecting a medical devices consultant to help your organization with GMP, quality and compliance concerns can be daunting for any Quality executive. This is especially true for new or smaller companies that do not have existing relationships with consulting firms or solo consultants.

Selecting the right medical devices consulting firm is often one of the most important decisions an executive will make, mostly because projects in this functional area are so critical to a company’s business performance, and a project’s success is contingent on the selected firm’s competency and ability to achieve desired outcomes.

The following are some points for consideration.

· Specialization

· Thought Leadership

· Activeness in Industry

· Resources

· In-person Discussion

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.