Medical Device Manufacturing

For Medical Device Manufacturers, a CMMS is Critical to Ensure Compliance with Regulatory Sandards

Medical devices are intricate in design and are manufactured using strict guidelines. Defects are not acceptable in the manufacturing process since the end products are often used to save human lives.  There are strict guidelines defining the medical device industry and proper procedures that must be followed when manufacturing devices. Proper maintenance records are imperative to ensure compliance with regulations and to FDA standards, such as 21 CFR Part 11.

Using Maintenance Connection’s simple, easy-to-use web-based CMMS application can help your medical equipment manufacturing operation extend asset life, track maintenance costs, prevent and predict equipment failures, improve labor productivity, reduce costly downtimes, minimize investments in inventory, and lower the total cost of maintenance.

Maintenance Connection software includes features to help medical device manufacturers like:

  • Electronic Signature Capture
  • Complete Audit Trail of any changes to records in the system
  • Configurable procedures to build electronic task checklists where each task must be signed off as complete
  • Canned reports that can be used to demonstrate regulatory compliance
Medical device manufacturers can set up maintenance procedures and preventive maintenance schedules to manage facilities and equipment in the following areas:
  • Material Loaders
  • Packaging Equipment
  • Cooling Equipment
  • Roboticsmedicaldevices
  • Grinders
  • Heat Transfer Equipment
  • Automation Systems
  • Heavy Machinery
  • Power Control/Generators
  • Metal Fabrication Systems
  • Pumps
  • Electrical Panels
  • Turbines
  • Material Handlers
  • Controllers