Quality Tech Services, Inc. offers environmentally controlled clean zones for turnkey manufacturing, assembly, packaging and labeling for finished medical devices. We are ISO 13485 certified and FDA compliant and have the capability to develop innovative solutions in a wide range of scenarios inside and outside a cleanroom environment. We offer medical device companies quick and cost-effective services for cleaning, assembly, packaging and labeling operations. Our three certified ISO Class 7 (10,000) Cleanrooms have been designed for optimal performance and process flow. We have an attached cleaning and passivation room for efficient transfer of material goods, as well as environments geared specifically for non-medical applications.

• ISO 13485
• FDA 21 CFR 820 Compliant
• MN Drug Manufacture License
• Ultrasonic Cleaning & Passivation
• High and Low Volume Capabilities
• Materials Procurement
• Full Traceability
• Contract Sterilization
• Modular Designs for Optimal Efficiency

A commitment to Quality and years of experience in this evolving market ensure products are manufactured on time with strict adherence to FDA Quality System Regulations (QSRs). We utilize TUV Product Services as our Notified Body to monitor and certify our facility to ISO 13485.

Quality for Life. “We are Passionate about Quality, as the services we provide improve the Quality of Life for Others.”