Remediation - Medical Devices

Medical device manufacturers receive observations (Form 483) and / or warning letters on completion of USFDA Audit. The document outlines any violations of Good Manufacturing Practices (GMP’s) such as the facility, equipment, processes, controls, products, employee practices or records.

Companies require substantial number of unplanned resources, budgets & at the worst are declined an opportunity to sell, shutting down facilities and even prosecution of responsible individuals until the observations are cleared. Companies may also undertake product remediation to resolve issues that they are aware of in their product design and development process.

IZiel has successfully assisted medical device companies to resolve these observations with efficiency and accuracy. 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.

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.

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 from USFDA.

IZiel can help companies understand the gaps in their design and development process in a methodical and comprehensive manner. IZiel’s process-driven & outcome-based delivery approach, quick scalability of resources, sound project management and flexible onshore-offshore model throughout all phases of the remediation are the key enablers of success.

IZiel can provide quick scalability of the skilled resources with knowledge of Design, Process Engineering & Validation, Systems Engineering, QMS and Regulatory to achieve outcome-based deliveries. The IZiel team comprises of experts in the Medical Device Industry and has a highly trained and experienced off-shore team. This team not only consults but also helps in implementation of the solutions identified.

Our founding principles to work for remediation projects –