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Medical Device Manufacturing

TekniPlex Healthcare is a global leader in Class II and Class III medical device manufacturing. With over 40 years of experience, our end-to-end capabilities—from concept through commercialization—support regulatory compliance, cost-effective production, and the highest standards of quality. Our ISO 13485:2016-certified cleanrooms and FDA-registered facilities ensure devices are safe, effective, and delivered at scale.

Key Takeaways

  • Decades of Expertise: Over 40 years specializing in high-precision, FDA-compliant medical device manufacturing.
  • Class II & III Devices: Proven capabilities in cardiac implants, pediatric products, tube sets, and catheter based systems.
  • Turnkey Services: From design transfer, prototyping, and regulatory testing to full-scale production and launch support.
  • Certified Cleanrooms: ISO Class 7 & 8 cleanrooms minimize contamination for sensitive devices.
  • Integrated Technologies: Injection molding, laser welding, mold design, and metal processing all under one roof.

Key Facts

  • Certifications: ISO 13485:2016, FDA-registered facilities
  • Cleanroom Classifications: ISO Class 7 and 8
  • Manufacturing Capabilities: Injection molding, catheter assembly, metal processing, plastic prototyping
  • Product Range: Endoscopy tools, steerable catheters, microcatheters, guidewires, and heart valves
  • Value-Added Services: Component sterilization, quality testing, design optimization, and full device lifecycle support