In medical device manufacturing, product quality is of the utmost importance. You need proven, trusted manufacturing processes and systems that deliver a quality product every time. You also need quality checks in place to alert of any deviations or station performance issues that could impact the products leaving your production line.
Sciemetric is experienced in how to test medical devices. Sciemetric serves medical device manufacturers with data acquisition, collection, and analytics systems, consolidated into a central source, by serial number, that enables complete traceability to 100% of parts. Sciemetric’s data analytics tools assist with the DOE (Design of Experiment) phase and make it easy to set up and continuously manage your manufacturing processes to required specifications.
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Improve medical device product testing and manufacturing process, product quality
The first step in ensuring a quality product is ensuring a quality process at each stage in the production line. Sciemetric’s monitoring and analysis systems help you design (DOE) and set up your manufacturing processes and tests with confidence. Sciemetric’s tools enable automated inspection of the critical-to-quality processes on your line, collecting part production data and/or machine data, then easily analyze your data to find the best test limits and solve problems.
Once production is running, you need to make sure your line is set up to alert you of deviations. These tools identify both real-time deviations (including using SPC-enabled real-time alerts) but also allow for quick analysis of anomalies in support of CAPA procedure for medical devices (Corrective and Preventive Action). Access digital records at any time, organized by serial number, to actively monitor enterprise-wide manufacturing with dashboard views of yield, defects, and quality reports, etc.
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Speed up root cause analysis and CAPA, more efficiently handle product quarantines
By collecting data from every process a device goes through in production, and digitizing your production records, you have a complete picture of part and line health. That means you can pinpoint root cause and take Corrective and Preventive Action (CAPA) much faster.
In the event of a product issue, Sciemetric’s software suite allows you to analyze and compare millions of historical digital process signatures from production processes to pinpoint specific production problems at the lot or even serial number level. You can then use these tools to identify how to fix and prevent the problem from happening again. You’ll get the reports you need to prove that you’ve identified root cause and controlled the issue, so you can resume manufacturing faster.
With our accessible QualityWorX database, you can ensure consistent quality measures and compare station performance across plants or the whole enterprise, domestically and internationally.
Implement non-destructive testing (NDT) methods, reduce scrap and subjective methods
Sample testing—common in the medical manufacturing market—is a destructive testing technique that removes a percentage of parts from production to perform field tests to gauge quality. This technique inevitable ends with a high percentage of wasted, scrap parts—and is still largely subjective. When you switch to Sciemetric’s IPT solution, you identify and remove only defective products. Traceability gives you a quality record for each device while reducing scrap.
DISCUSS MORE EFFICIENT MEDICAL MANUFACTURING PROCESSES WITH OUR EXPERTS
Quickly characterize the process during product development, bring your product to market
Sciemetric technology helps development groups quickly understand the manufacturing processes so you can get through your DOE process and get new products to market faster. We’ll show you how to identify and control process variation, prove that the automation processes are under control, and produce evidence that new equipment is operating the same as validated machines, all using reliable, traceable data.
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