Cleanroom Assembly of FDA and
CE Certified Medical Devices

Complex medical device assembly within cleanroom

Cleanroom Medical Device Assembly

Europlaz cleanrooms are designed for quality assembly of advanced medical devices

Operations are tailored to meet specific customer needs. Europlaz has experience in assembly of complex devices for the pharmaceutical, drug delivery, medical and healthcare industries.

Components can be outsourced directly by Europlaz and plastic parts injection moulded within the same ISO certified cleanroom as the production cell.

FDA & CE approved medical devices:

  • Multi component, multi material assembly
  • Manual and automated services
  • High and low volume assembly
  • Dedicated customer production cells 
  • Flexible batch/lot sizes, ideal for product start-ups

Cleanroom Assembly     

 

Typical processes include:

  • Ultra sonic welding
  • Hot plate welding
  • Liquid filling
  • Laser cutting
  • Multi solvent bonding
  • UV curing
  • Hot wire welding
  • Testing

To prevent product contamination, Europlaz follows strict rules and procedures meeting specified air flow rates, pressurization, temperature, humidity, and specialized filtration.

We are committed to meeting ISO 13485, FDA and GMP standards at all times.