komax USA
 

Professionals in Advanced Automation

Medical Device Assembly

Medical devices – quality guaranteed through comprehensive knowledge of the industry

Introduction

To be successful as a supplier of medical devices assembly systems, a company must have comprehensive knowledge of the industry, must comply with FDA standards and clean-room requirements and must be able to process special materials.
Drawing on innovative technologies and our comprehensive knowledge of applications, we can integrate various processes seamlessly into high-performance systems. The tasks range from assembly and gluing of needles, catheter tip forming, and volumetric dosing of lubricants to coiling flexible tubes, integrated weight monitoring, and much more. Close collaboration even at the product development stage guarantees optimum process parameters and robust solution.
  • A wide range of applications: inhalers, drugs and insulin delivery systems, needles and catheters, test and diagnostic instruments, etc.
  • Modular system designs: a wide range of automated assembly machines and platforms
 
  • Comprehensive knowledge of the critical processes in the assembly of medical devices
  • A wealth of experience in supporting FDA validation (DQ, IQ, OQ and PQ) and in questions relating to compatibility with 21 CFR 820 (GMP) and 21 CFR Part 11