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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.
IZiel helps you to obtain US FDA and CE approvals for Class I, II & III Medical Devices. Our Regulatory Consultants in US, Europe and India have thorough knowledge of USFDA & MDR Requirements alongwith extensive experience in submissions and approvals. IZiel works with the company to develop comprehensive documents in compliance with the regulatory requirements.
All those in medical device industry must be aware that MDR (EU Medical Device Regulation) which was postponed for implementation due to corona pandemic. The due date in now approaching fast which is May 26, 2021. So, are you prepared all device manufacturers who are selling in Europe?
We are sure that you must be aware that changes between old MDD (Medical Device Directive) and MDR are significant and lot of new requirements…
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.…Continue