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USFDA Consulting Firms

Posted by Aniket Chaudhari on May 18, 2024 at 2:59am 0 Comments

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…

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MDR Consultants

Posted by Aniket Chaudhari on May 18, 2024 at 2:59am 0 Comments

IZiel Healthcare are leading providers of engineering and regulatory services for MDD to MDR projects for medical device companies.IZiel helps you to obtain CE approvals for Class I, II & III Medical Devices, along with MDD to MDR transitions.

Read more@ https://iziel.com/ce-approval-mdr/

Regulatory Remediation Services

Posted by Aniket Chaudhari on May 18, 2024 at 2:58am 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.

Read more@…

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Posted by Margaret on May 18, 2024 at 2:57am 0 Comments

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