QUALITY

We maintain strict quality standards for customers in several industries. 

• ISO 13485 Certified (click to view)

• 21 CFR Part 820

• Process Validations: IQ-OQ-PQ

• Class 8 and 7, (Formerly Class 100,000, 10,000) clean room molding

• ISO Class 6, (Formerly Class 1,000) assembly clean room

• SPC monitoring and printing press side

• Latex and DEHP free manufacturing facility

• cGMP