IZiel Healthcare is an Engineering & Regulatory Service Provider working on design, process validation & improvement, engineering documentation, software validation, risk management, USFDA  Approval and/or remediate the observations (483), resolve findings from warning letters for medical device companies.

Our approach for an Outcome-Based delivery along-with the Cost-Effective Model by combining teams from India & US has worked very well for customers in USA, Europe and Asia. Strong Domain Knowledge, Technical Competency and Comprehensive Evaluation and Monitoring System ensure effective and timely deliveries across a variety of Class I, II and III devices.

Along with our Partners in USA, we work on various Regulatory & Remediation Projects for large Medical Device Companies. 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.

IZiel Work Model
We complete all projects on the basis of these 5 strong principles.

IZiel Team follows a detail-oriented approach and works with the engineering and quality teams to ensure that all the necessary documentation for design, process validations, software validations, risk management along with compliant quality system procedures are created. We adopt the V-Model methodology along with a Design for Six Sigma approach to document and validate the product. In the process, we also train the engineering and the quality teams at the client’s location and ensure a lasting change is made in the organization to continue producing quality products consistently.