Packaging & Assembly

Assembly

Early on in design and development, ATL’s processes start the PFMEA (Production Failure Modes and Effects Analysis). Design concepts are reviewed for manufacturability; needed tools and fixtures are identified. This provides ample time for the IQ, OQ, and PQ processes to be considered for required equipment.

When a product has been released to manufacturing and assembly, you can rest assured that our ISO 13485 Quality Management System has a robust manufacturing plan.

 

Packaging

Product manufactured in our ISO 8 clean room or clean area can also be packaged by ATL. Our processes control the final packaging process using robust RF sealing for predictable and controlled Tyvek™ pouch sealing.

Our packaging areas employ high precision coupon seal pull test equipment to verify the equipment functionality at the beginning, middle and end of each shift. This critical information is retained by ATL to ensure a complete and detailed Device Master Record. To ensure compliance with UDI, ATL employs robust software systems to track labeling requirements for printed labels, laser engraving or other marking processes.

Manufacturing Capabilities:

  • Automated Cutting, Stripping
  • Fiber Optic Termination
  • Cable, Component, and Device Assembly
  • Pin Loading
  • Kitting
  • Crimping
  • Heat Staking
  • UV Curling
  • Wire Stripping
  • Automated Crimping
  • Thermocouple Manufacturing
  • Soldering
  • Ultrasonic Welding
  • Solvent Bonding
  • Tack Welding
  • Clean Room
  • Heat Sealing
  • Sterile and Non-Sterile Packaging