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Regulatory Remediation Services
Posted by Aniket Chaudhari on February 25, 2025 at 11:32pm 0 Comments 0 Likes
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.
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ContinueFDA Remediation Consultants
Posted by Aniket Chaudhari on February 25, 2025 at 11:31pm 0 Comments 0 Likes
Remediation Consultants at IZiel implement best practices in Design-Development Process and Quality Management Systems ensuring effective and timely deliveries. IZiel provides expert solutions to remediate 483 observations and warning letters. IZiel teamworks with medical device companies across the globe to achieve regulatory andstandard compliance.
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