Micro sized components are often the enabling components to Class II or III medical or drug delivery devices and, because of their size, require micron-level (0.0000397”) tolerances. Micro molding drug delivery devices to micron tolerances requires a solid risk assessment and a correspondingly extreme fine tuning of existing injection molding technologies. A case study for this risk assessment strategy for a Class III implantable drug delivery device with total tolerance of 16 microns for a polymer part is the basis of this paper.


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