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MDD to MDR
Posted by Aniket Chaudhari on September 23, 2024 at 5:24am 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/
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Posted by smithmorgan on September 23, 2024 at 5:24am 0 Comments 0 Likes
Configuration Management for Medical Device
Posted by Aniket Chaudhari on September 23, 2024 at 5:23am 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.
Read more@…
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Posted by smithmorgan on September 23, 2024 at 5:23am 0 Comments 0 Likes
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