CLASS 7 CLEANROOM SERVICES
Primo Medical Group’s combination of vertically integrated manufacturing capabilities as well as FDA Compliant assembly sites distinguishes us from other suppliers by providing you with a single point of contact for your outsourcing needs.
Our ISO Class 7 clean rooms, with combined 15,000 square feet of space meet FDA Quality System Regulations, ISO 13485:2016, ISO 9001:2008, FDAQSR Compliant.
We provide finished device assembly to meet our customer’s highest expectations.
Depyrogenated UltraSonic Cleaning
- Solvent and Adhesive Bonding
- Ultrasonic Welding
- Mechanical Assembly
- Laser Welding and Marking
- Laser Drilling and Cutting
- Testing and Validation
- Custom Packaging and Labeling
- Medical Device Pad Printing
These services performed with:
- USP Class VI medical grade ink
- Oven Curing
- Metals, Plastics, Silicone
- Small and Large Volumes
- Burst, Pressure Decay and Tensile Testing
- R.O. Water Supply
- Latex Free Environment