Assembly

Modern medical devices assembly technologies must adhere to product and regulatory requirements. With rapid development of advanced production automation, process control, information technology and networking it is possible to achieve more flexibility and scale production. It is important to take the purpose of the product into consideration to find the most efficient way of assembling it. From completely manual to fully automated processes SteriPack offers top quality resources required to set up effective production lines.  

Our facilities are supported by experienced and knowledgeable personnel along with the cutting edge machinery necessary to provide the highest quality medical device assembly solutions from conception to finished market goods. Our capacity is expanding and we are always prepared to set up efficient, cost-effective assembly lines for our customers, performing end-to-end testing to ensure specifications are met, high performance and much more. We share expertise and ideas from small to large-scale production to increase optimization of the assembly process and find the most competitive solutions.

As an FDA and ISO 13485 compliant manufacturer, we ensure service that meets the most demanding standards. From manual to fully automated assembly, all operations are carried out in ISO Class 7 and 8 clean room to provide our customers with reliable, high quality services.

Our medical devices assembly services:

  •  Ultrasonic and spot welding
  •  Heat staking
  •  Labeling
  •  Pad and laser printing
  •  Bonding
  •  Crimping
  •  Kit packaging
  •  Functional testing

Our operational excellence program:

  •  Continuous manufacturing flow
  •  Vision system control
  •  Documented employee training for our highly skilled operators and technicians
  •  Traceability reports generated for each build
  •  Dedication to the principles of lean manufacturing and 5S
  •  Kanban for fast response and lower inventories
  •  Kaizen for cost reduction and performance requirements

Key features:

  •  Clean room medical devices assembly in ISO Class 7 and 8 environments
  •  Manufacturing pilot lines to debug, analyze, validate compliance and finalize for production
  •  Process Failure Mode and Effect Analysis (FMEA)
  •  Epoxy UV curing assembly, mechanical assembly, part pouching and sealing and tray sealing from sub assembly to delivered, sterile devices
  •  Verification and validation testing: tensile, compression and torque testing, leak testing by pressure decay and flow rate

Typical application areas:

medical devices elements and whole ready to use devices. 

Medical device cleanroom assembly