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MDD to MDR Consultant
Posted by Aniket Chaudhari on December 17, 2024 at 12:34am 0 Comments 0 Likes
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/
Medical Device Software Validation
Posted by Aniket Chaudhari on December 17, 2024 at 12:33am 0 Comments 0 Likes
IZiel has highly trained software engineers with multiple years of experience in software coding, software verification and software validation. The team consists of senior engineers who have worked in design and development of highly sophisticated implantable devices at industry leading companies, with direct expertise in software V&V. This team, with the support of IZiel’s regulatory and clinical experts, are decidedly equipped to handle complex software validation activities for…
ContinueRemediation for Medical Devices
Posted by Aniket Chaudhari on December 17, 2024 at 12:33am 0 Comments 0 Likes
IZiel team in collaboration with the customer utilize an extensive & comprehensive methodology to complete the remediation project. Our Onshore-Offshore Model with strong project management ensure deliveries with faster timelines, flexible resources and in cost-effective manner.IZiel utilizes the best practices in design and development while ensuring compliance with regulation to ensure a speedy and compliant design and development process.
Read more@…
ContinueUSFDA Consulting Firms
Posted by Aniket Chaudhari on December 17, 2024 at 12:32am 0 Comments 0 Likes
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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