Regulatory Remediation Services

Free

Details

Location

India Maharashtra - Pune

Category

Services > Other Services

Published Date

06-12-19

Visitors

12

Description

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) and resolve queries, if any, from USFDA.

https://iziel.com/regulatory-remediation/

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Regulatory Remediation Services