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MDD to MDR
Posted by Aniket Chaudhari on February 18, 2025 at 12:13am 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/
Configuration Management for Medical Device
Posted by Aniket Chaudhari on February 18, 2025 at 12:13am 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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ContinueForm 483 Compliance
Posted by Aniket Chaudhari on February 18, 2025 at 12:12am 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/
International Women's Day Offer: Indian Eagle's Special Discounts
Posted by IndianEagle on February 17, 2025 at 11:58pm 0 Comments 0 Likes
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