Pro-Tech Design & Manufacturing, Inc.

PRO-TECH Design & Manufacturing, Inc.

A Partner You Can Trust

PRO-TECH Design & Manufacturing is a full-service, ISO 13485 registered medical device contract manufacturer. Our services include contract packaging, assembly, and sterilization services.

For 45 years, we have provided best-in-class service to hundreds of medical device customers, large and small.  We pride ourselves on forming long-term partnerships with our customers.  In fact, our very first customer from 45 years ago is still one today.

We are a woman and family-owned company focused exclusively on the medical device industry. This gives us flexibility to quickly adapt to changing market conditions and to provide customized service depending on each customer’s unique requirements.  We are not interested in a one-size-fits-all approach and neither are our customers.  They don’t want to be slotted into a rigid model that’s not right for their situation, and we strive to meet them where they are and develop tailored packaging, assembly, and sterilization solutions that address their specific needs.

We offer three convenient locations near medical device hubs in Southern California, Minnesota, and Texas with redundant production resources and capabilities. Each site is FDA registered and features Class 10,000/ISO 7-rated certified cleanrooms.  As such, you have multiple options to locate the assembly and packaging of your device to a facility that meets your exact specifications. 

Our capabilities include:

Packaging Services:

• Packaging Design
• Pre-Validated Packaging
• Packaging Material Expertise
• Pouching – High-Speed Pouching Lines
• Trays – Rigid Tray Lines
• Liquid Filling – Syringes, Vials, and Tubes
• Custom Boxes, Foam, and Inserts
• Cartoning/Multi-Packs
• Heat-Sealed Carding
• Shrink Wrapping

Assembly Services:

• Class 10,000/ISO 7-rated Cleanrooms
• Flexible Assembly Solutions
• Hand-Assembly & Automated Production
• Form-Fill-Seal
• Kitting
• Drug + Device Combination Capability
• Production Time Studies
• Experienced Manufacturing Engineers
• Multi-Component Assembly

Sterilization Services:

• ISO 17665 Certified Steam Sterilizer
• Managed 3^rd Party Relationships for Ethylene Oxide and Gamma
• Validation and Cycle Development
• Experience Matching Packaging to Sterilization Method
• Mixed Pallet Loads Minimize Cost & Time

Laboratory Services:

• Packaging Validation Testing
• ISO 17025 Certified Lab In-House
• Accelerated & Real-Time Aging
• Bioburden & LAL Testing
• TOC Testing
• Peel Strength Testing
• Bubble Leak Testing
• Distribution Simulation