Medical Device Software Validation

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/

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 medical device manufacturers. Read more@ https://iziel.com/software-validation/

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@ https://iziel.com/remediation/

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 Approvals. Read more@ https://iziel.com/usfda-approval/

Remediation Consultants at IZiel implement best practices in Design-Development Process and Quality Management Systems ensuring effective and timely deliveries. IZiel provides expert solutions to remediate 483 observations and warning letters. IZiel teamworks with medical device companies across the globe to achieve regulatory andstandard compliance. Read more@ https://iziel.com/remediation/ 

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/

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 medical device manufacturers. Read more@ https://iziel.com/software-validation/

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@ https://iziel.com/remediation/

IZiel alongwith their partners (Obelis) provide a “One-Stop Shop” to assist medical device manufacturers 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/ 

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@ https://iziel.com/configuration-management/ 

 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@ https://iziel.com/configuration-management/

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/ 

Medical Device Manufacturers require USFDA Approvals to sell their products in USA. USFDA differentiates product approvals in Class I, II &III depending upon the risk associated. The submissions include self-certification, 510(k) and PMA depending upon the class of the product.IZiel implements an Outcome-Based Delivery Model to provide complete solution from developing engineering documentation to receiving USFDA Approvals & establishment registrations thereafter. Our teams from USA & India collaborate to develop a Cost-Effective Model to complete USFDA Approvals for customers in USA, Europe and Asia. Read more@ https://iziel.com/usfda-approval/

In the realm of medical device manufacturing, ensuring product quality and compliance with regulatory standards is paramount. A robust Quality Management System (QMS) is the cornerstone of this endeavor, providing a structured framework for managing processes, documentation, and continuous improvement. This blog aims to delve into the essentials of QMS documentation for medical devices, shedding light on key components, regulatory requirements, and the pivotal role it plays in ensuring product safety and efficacy.   Understanding QMS Documentation:   A Quality Management System is a structured framework designed to manage and enhance the quality of products or services. In the context of medical devices, a QMS is not only a regulatory requirement but also a crucial tool for ensuring that devices meet the highest standards of safety and performance.   Key Components of QMS Documentation:   1. Quality Policy and Objectives:    - Begin with ...

Remediation Consultants at IZiel implement best practices in Design-Development Process and Quality Management Systems ensuring effective and timely deliveries. IZiel provides expert solutions to remediate 483 observations and warning letters. IZiel teamworks with medical device companies across the globe to achieve regulatory andstandard compliance. Read more@ https://iziel.com/remediation/

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/

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 medical device manufacturers. Read more@ https://iziel.com/software-validation/

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@ https://iziel.com/remediation/