ISO 15415
Background
Certifies the implementation of a GS1 2D Data Matrix (a scanable bar code) on all class 1 medical devices so each device can individually be tracked from production to the when it lands in the surgeons hands. When the bar code is scanned it reads, out a Unique Device Identifier (UDI) number that gives the device a unique 13 digit number followed by the lot number. The numbers in parentheses are device identifiers that separate the 13-digit number from the lot number.
GS1 2D Data Matrix
Unique Device Identifier Number
Updated 8 systems (82 SolidWorks Drawings and 8 ECO's) to include the GS1 2D Data Matrix as well as the UDI number. Determined where the matrix and UDI number would be placed, based on the location of previous laser markings. Below is an example of how the matrix and UDI number was implemented.
(Unique Device Identifier Number)
In order to perfect the laser marking of the GS1 2D Data Matrix, I communicated with vendors to ensure the quality of the matrix passed the ISO specification. Determined that the matrix had to be placed on a silver matte background in order to increase its readability; the matte finish increased the contrast of the image allowing for a more accurate reading.
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Created laser marking guidelines ​to assist the employees of the company on how to properly chose the correct matrix and how implement it on their parts. Depending on the part, a square or rectangular matrix would be used; spacing and thickness of the part would determine which matrix would be used. Other factors such as proper spacing from adjacent laser markings, font size, and font type were also take into account. In conjunction with the guidelines, I authored a laser marking specification guideline, which in summary, ensures the vendor verifies the quality of the matrix before SpineFrontier receives the part. As indicated below a 0.5 grade matrix is considered passing according to ISO, but to ensure the best quality matrix, SpineFrontier will only accept matrices above a 2.5 grade.
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The data matrix and text could not physically fit on all parts, so I authored a memo to outline which parts were exempt from the either the data matrix and/or UDI number due to its size or feasibility. The memo was submitted to the FDA for final ISO certification.