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Articles

Published 2 Years Ago
Transitioning from MDD to MDR – Part 1
IZiel alongwith their partners (Obelis) provide a “One-Stop Shop” to assist medical devicemanufacturers for MDD-MDR transition.

Published 2 Years Ago
Why it’s important to work with US FDA consultant for compliance.
IZiel adopts an analytical mindset thus enabling us to root out all possible non-conformances in a regulatory submission.

Published 2 Years Ago
Difference between Form 483 observation & warning letter
IZiel provides expert solutions to remediate FDA 483 observations and warning letters. IZiel team works with medical device companies across the globe to achieve regulatory and standard compliances.

Published 2 Years Ago
Do you know about risk management for medical devices
IZiel Healthcare provides Process Validation for Medical Devices which includes IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification), TMV (Test Method Validation) etc.