Cleanroom Manufacturing for Medical Device OEMs

Certified cleanrooms for finished medical devices, complex components, and sub-assemblies.Lots of contract manufacturers say they have a "cleanroom".  

At one end of the scale, this is actually just a room that is clean...

At the other end of the scale is a true, Certified Cleanroom.  We do our manufacturing in true Certified Cleanrooms. This requires on-going environmental monitoring and maintenance in concert with outside, independent certification.

Medical devices need to be commercialized using robust cleanroom manufacturing practices, so ask for a Certified Cleanroom and be sure to check the certification records for compliance.

Some of our qualifications include:

  • Class 7 (10,000) Certified Cleanroom
  • Class 8 (100,000) Certified Cleanroom
  • Cleanroom Injection and Insert Molding
  • FDA Registered
  • ISO 13485
  • ISO 9001

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