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Posted by Aniket Chaudhari on April 19, 2024 at 4:59am 0 Comments 0 Likes
IZiel alongwith their partners (Obelis) provide a “One-Stop Shop” to assist medical devicemanufacturers for MDD-MDR transition. IZiel ensures to focus on regulating medical devices throughout its lifecycle rather than focussing on any one stage, which is the need of MDR. The MDR seeks to address these concerns so that the end users do not face major safety or quality issues.
Read more@ https://iziel.com/ce-approval-mdr/
Posted by Aniket Chaudhari on April 19, 2024 at 4:58am 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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ContinuePosted by Aniket Chaudhari on April 19, 2024 at 4:57am 0 Comments 0 Likes
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 on December 2, 2021 at 10:30am 0 Comments 0 Likes
Packaging issues are one of the essential aspects of business that must be properly addressed. It provides the solution for the proper handling and protection of products. Critical solutions are even more important if we are going to look at the requirements of the food business. Food packaging is easily one of the most Visit website vital aspects of packaging solutions requiring the strictest standards in terms of safety and…
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