Medical Devices Must Meet the Highest Standards of Safety, Reliability, and Quality

MEDICAL DEVICES

The consequences of poor quality in medical device manufacturing can range from an FDA warning letter to lawsuits and criminal prosecution. That means quality inspection is crucial to ensure proper documentation and compliance to standards. But the process of documenting quality inspections can be very costly and error-prone without the right tools for the job.

Whether you are a medical device manufacturer looking to manage quality inspections within your supply chain or a supplier looking to meet your customer’s stringent quality requirements, InspectionXpert OnDemand can help you.

Start Saving Time Right “Out Of The Box”

InspectionXpert comes with a variety of inspection report templates to help you get started.

Ready to start? Request a free trial today to start saving time and preventing errors right away.

 

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  • Reduce the Chance for Errors with Automation

    InspectionXpert Ondemand can:

    • Help you with your ISO 13485 and FDA 21CFR Part 820 QSR processes
    • Automate the identification and extraction of inspection characteristics (e.g. dimensions, tolerances, etc…) from your 2D CAD drawings and 3D CAD models (CATIA only for 3D).
    • Read 2D and 3D CAD drawings 
  • Improves Speed and Accuracy

    InspectionXpert OnDemand has first article inspection solutions and work in process (WIP) or in-process inspection automation solutions for most CAD drawing formats, including PDF and TIFF, that enable you to quickly add balloons or bubbles to identify dimensions on your drawing.

    The software reads the dimension values directly from the CAD system (e.g. CATIA, SolidWorks, etc…) or from a PDF and/or TIF file via optical character recognition (OCR), providing significant improvement in both speed and accuracy over manual methods.