Manufacturing Solutions for Medical & Healthcare Products

Medical and healthcare products require controlled processes, consistent quality, documentation and batch traceability.

Simblong supports selected medical and healthcare plastic components, equipment housings and subassemblies through coordinated engineering, tooling, cleanroom molding, inspection and traceable manufacturing.

Industry Requirements

▪ Material and specification control 

▪ Consistent dimensional quality 

▪ Controlled production processes 

▪ Clean manufacturing capability 

▪ Batch and process traceability 

▪ Documented inspection and issue closure 

Product Applications

▪ Medical equipment housings 

▪ Diagnostic instrument enclosures 

▪ Handheld healthcare device housings 

▪ Structural plastic components 

▪ Buttons, covers and control components 

▪ Non-sterile plastic subassemblies 

▪ Healthcare product accessories 

Relevant Capabilities

▪ DFMA and manufacturing-risk review 

▪ Precision mold manufacturing 

▪ Class 100,000 cleanroom injection molding 

▪ Engineering-plastic processing 

▪ In-process inspection 

▪ Product-specific assembly and testing 

▪ MES and batch traceability 

▪ ISO 9001 and ISO 13485 quality systems

Manufacturing scope, material requirements, validation standards and regulatory responsibilities are reviewed individually for each medical and healthcare project.