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Configuration Management for Medical Device

Posted by Aniket Chaudhari on May 6, 2024 at 2:25am 0 Comments

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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Form 483 Compliance

Posted by Aniket Chaudhari on May 6, 2024 at 2:24am 0 Comments

IZiel provides expert solutions to remediate FDA 483 observations and warning letters. IZiel team works with medical device companies across the globe to achieve regulatory and standard compliances. We take great pride in implementing best practices in Design-Development Process and Quality Management Systems ensuring effective and timely deliveries.

Read more@ https://iziel.com/remediation/

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Posted by Edward on May 6, 2024 at 2:21am 0 Comments

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