Case studies on various types of projects completed by the IZiel team for Class I, II & III medical devices.

Process Validation

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Software Validation

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USFDA Approval

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Complaints Handling

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Acquisition Integration

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MDD-MDR Transition

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Fixture Design

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Literature Search and Study

Clinical evaluation in healthcare involves assessing the safety and effectiveness of medical interventions or devices in humans. This process requires a thorough literature search to collect relevant...

What is Post-Market Clinical Follow-up?

PMCF study is carried out for CE certified medical devices that are placed in the market. It’s a method of proactive collection of clinical data to analyze the emergent risks/side-effects of the...

What is Clinical Evaluation?

It is the process to generate clinical evidence to establish the safety and efficacy applicable to all the classes of medical devices. The Clinical Evaluation should be drafted with the help of MEDDEV...

What is Post Market Surveillance?

Post-sale of medical devices, it is critical to monitor how efficiently the device is working, its downtime, any faulty findings, any risk it poses to the users, end-users etc. In short, continuous...


Post-Market Surveillance & Medical Device Regulation