Assembly, Kitting & Packaging

At Cretex Medical | QTS we provide device assembly, custom kitting, and validated packaging services designed specifically for your medical device. Whether you need to package a single component or assemble a complex multi-part device, our certified cleanrooms and expert team ensure every project is completed with exceptional quality. We make it easier to get your products to patients.

With QTS, you gain a dependable partner committed to quality, consistency, traceability, and compliance through:

• Validated systems and ISO-documented procedures
• ISO Class 7 (10,000) certified cleanrooms and cross-validated equipment
• A robust Quality Management System
• Highly trained technicians who ensure accuracy and accountability

From assembly to final packaging, your products are in good hands.

Packaging regulations for medical devices are complex and constantly evolving. That’s why our experts stay ahead of industry changes and:

• Interpret the latest packaging standards
• Explain the “why” behind our process recommendations
• Help you meet compliance requirements with confidence
• Work with you to plan and execute final cleaning, assembly, packaging, labeling, and sterilization validations

We don’t just meet regulations, we help you understand them.

Our production teams are cross-trained, and we maintain redundant cleanrooms and equipment to ensure project continuity. This allows us to:

• Shift resources quickly between projects
• Prevent downtime or delivery disruptions
• Maintain high quality and efficiency across every job

It’s just one more way QTS goes the extra mile for our customers.

Our in-house assembly services can be performed in one of our cleanroom environments. Our wide range of capabilities includes:

• Sealing & Packaging:
  • Pre-validated or custom tray sealing
  • Pre-validated or custom pouch sealing
  • Form-Fill-Seal, flexible packaging (medium to high volume)
  • Vacuum sealing
  • Modified atmosphere pouch packaging (e.g. oxygen purge, nitrogen flush)
  • Secondary packaging and labeling
• Bonding & Fastening:
  • UV-cure adhesive bonding
  • Ambient-cure adhesive bonding (e.g. cyanoacrylate)
  • Solvent welding
  • Ultrasonic welding
  • Riveting
• Component & Kit Assembly:
  • Instrument assembly
  • Kit assembly (kitting)
  • Syringe modification & capping
  • Tubing sets
• Specialty Handling:
  • Temperature and humidity controlled material storage
  • Shelf life and date sensitive material handling
• Sports Medicine and Suture Product Assembly:
  • Suture cutting, tying, splicing
  • Needle swaging
  • Suture tipping
• Other Capabilities:
  • Serialized product management
  • Crimping
  • Silicone coating
  • Component coating