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.
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- 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
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- Comprehensive knowledge of the critical processes in the assembly
of medical devices
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- 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
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