OEM Medical Device Manufacturing
Pacific Plastics & Engineering offers all of the in-house benefits of custom design, assembly and for OEM medical device manufacturing. We consistently deliver defect-free products due to our precise attention to detail. This ensures the final unit matches your specifications. We offer fully automated assembly, cleanroom manufacturing, destructive testing and sterilization management.
Savings You Can Count On
Your medical device can be designed, assembled, and manufactured in our Silicon Valley facility or you might select the cost-effective option of our Asian facilities. Combination plans are available wherein some tools or components are manufactured overseas, and some remain in the U.S. The same Quality Assurance System is in place regardless of where your device is produced. This standard is comprised of:
- FDA registered
- Quality Management Systems registered to both ISO 13485:2003 and ISO 9001:2000
- Capabilities for CMM and Micro-Vu systems measurement
- SPC, Cpk, Gauge R and R, and DOE data available
- Assistance through IQ/OQ-PQ/PPW qualification
PPE can ensure your medical device products are ready when you need them and in the quantities you need. We offer Class 10,000 and 100,000 clean room assembly, with a full range of services including inspection, packaging & sterilization, assembly with in-process inspection, epoxy assembly and UV curing, mechanical assembly, part pouching and sealing, verification and validation testing, pull and torque testing, as well as stress testing.
