Validating device

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In the case of the surgical tool, the maximum range limits for both the weld-junction gap and the weld-spot location were derived from historical data.

The results of both gauge R&R studies successfully established the fit-up and laser weld-spot positioning capability.

If available, historical data from similar laser welding processes should be used to set the limits.

Otherwise, manufacturers should determine limit values using the Do E process.

Therefore, it was decided to add two nondestructive metrics that might correlate with the burst pressure: weld-spot location in relation to the weld-junction centerline and weld width.

The purpose of conducting a pre-Do E study is to select the variable input factors, fix certain input factors, identify input factors that represent experimental ‘noise,’ and determine the range for each variable input factor.

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In this case study, the variable input factors selected included peak power, pulse duration or pulse width, percent of weld-spot overlap, and weld-spot location in relation to the weld-junction centerline.

Steinmeier and Lisa Schaller In the medical device world, laser welding encompasses a wide range of applications and part sizes.

However, when laser-welding process cannot be fully verified, FDA requires that manufacturers validate them.

Such conditions are met when the process transfers, changes, or deviates from the validated state. This step involves setting up the equipment in accordance with the manufacturer’s installation specifications and verifying the equipment calibration.

Equipment manuals contain the key installation information required to ensure proper equipment operation.

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