Medical device manufacturers in the US are facing challenges on many fronts. How do they maintain product quality to satisfy FDA 21CFR Part 11 standards? How do they operate as efficiently as possible to keep costs down? How do they provide product traceability in the event of a product recall? And how do they satisfy their customer quality and delivery requirements?

The simple answer is data. The level of data requirements can be different based on whether the medical manufacturer makes disposable products or surgical implants.

Real-Time Data to Maintain Medical Product Quality and Traceability

PlantStar provides the following tools to help our medical product manufacturing customers achieve quality control, product traceability
and production efficiency:

  • Forward/Backward dynamic job and work order scheduling
  • Tool Change and material change scheduling
  • Manual and automatic scrap entry
  • Downtime alarms
  • OEE dashboard calculations
  • Family Tool Tracking
  • Labor Tracking and Forecasting
  • MRP/ERP integration
  • Assembly monitoring
  • Process variable monitoring and alarming
  • Traceability to every cycle of the machine
  • Auxiliary Equipment Monitoring
  • Material Lot Tracking
  • Audible/text/email messaging for shop floor alerts
  • Visual displays
  • Easy-to-use operator touch screen
  • Display of setup instructions, part images, quality instructions, packing instructions and more
  • Real-time UDI compliant bar code labels
  • Central systems monitoring

Medical Installations by PlantStar

BD Medical
Covidien Healthcare
Jarden Plastic Solutions
Rainin Inc.
Vention Medical