Quality is of utmost importance in medical device component manufacturing. LasX guarantees it.
At LasX, we’re as concerned about the quality of the parts we produce as you are. We’re dedicated to displaying how laser processing can manufacture world-class medical devices and components that can be held to the highest standards. We guarantee quality in three ways: by our ISO 9001:2000 certification, through our clean room, and by the collection of analytical data throughout the production process.
ISO 9001:2000 Certification
We’re passionate about the quality of the products we produce. Our ISO9001:2000 certification shows our commitment to quality and adherence to the highest international standards. Because of our certification, we’re better able to communicate with customers about how to incorporate quality-related practices directly into the production process. In addition, our Quality Management System allows our customers to achieve and maintain FDA approvals and simplifies the collation of related documentation. ISO - BSI Certificate
Clean Room Operations
LasX understands the critical importance of getting accurate results for IVD and assay tests. We also understand the issues that debris and contamination can create in the outcome of these tests. We operate our precision medical converting machinery in a certified Class 100,000 clean room (with the capability of going to class 10,000 if necessary). Our clean room allows us to maintain a high level of cleanliness during processing, insuring all customers receive world class quality components for their IVD and micro-fluidic devices.
SPC
We fully understand how to design processes with the repeatable high tolerance accuracy needed in the manufacturing and alignment of layers for structured laminated fluidic devices as well as for single layer components. LasX uses vision metrology equipment to monitor the converting process during startup, in process, and post run analysis. This data can then be entered into SPC software that provides results in an easily reviewed format. The format includes Histogram analysis and graphs along with data for Cp and Cpk.