Author: IZiel Healthcare

Engineering Services | CAD | FEA | Fixture Design | IZiel

IZiel Services has created a niche for itself in the field of Welding, Checking and Body in White (BIW) Fixture Design. Apart from fixture design, We've successfully completed various 3D... Read More

CE Approval | MDR Transition (2017/745) | IZiel

The new regulations passed by the Council of the European Union is Medical Device Regulations (MDR) 2017/745 & manufacturers have a transition time of three years until May 2024 to... Read More

USFDA Approval | 510(k) & PMA | IZiel

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... Read More

Medical Product Design & Development | IZiel

Our team has successfully completed and worked with various client teams to support in developing the Design and Development Plan, Design Verification, Validation Protocol and Reports, Design Transfer Plan and... Read More

Quality Management System | 21 CFR Part 820 | ISO 13485 | IZiel

IZiel Healthcare works with Class I, IIa, IIb & III medical device companies to develop / revamp the QMS to ensure complete product safety & efficacy. IZiel team works with... Read More

Software Validation & Verification | IZiel

IZiel’s approach for Software Validation is to identify gaps in the processes and documentation required as per IEC 62304, and assist medical device manufacturers to bridge these gaps & performed... Read More

Process Validation & Verification | IQ PQ OQ | IZiel

Process Validation is conducted to ensure consistent delivery of quality products meeting its predetermined specifications/requirements and quality characteristics. We take great pride in implementing best practices & effective and timely... Read More

Medical Devices – Product Development & Engineering Support – IZiel Healthcare

IZiel helps client with end-to-end product development at every stage of product life cycle. Our dedicated and talented team, focuses on multiple products and engineering disciplines, enabling clients to create... Read More