Lemax GmbH is providing a full project management to assure that you will get the best solutions for your challenges. Having many years of experience in development and manufacturing of Class I, II, III and AIMD medical devices in different companies we can be the key to lean projects, reduced costs and short realization times. A regular reporting will provide transparency in the projects.


Portfolio

• Feasibility studies, concept evaluations and designs
• Material and coating definitions
• Technical file compilation for CE certification
• Design qualification and validation
• Technical file compilation for CE certification
• Risk analysis
  
• Sourcing of prototypes
• CTI project management

• All plastic part production techniques as injection molding, extrusion, thermoforming, machining, welding etc.
• Project management and documentation
• Cost controlling
• Process and product risk analysis,  FMEA
• Process validation
• Contamination control  Bioburden / Cytotoxicity
• Packaging and sterilization
• Microtechnology
• Biomedical engineering
• Development of Active Implantable Medical Device
• Development of catheters
• Development of minimal invasive instruments
• Technical file compilation for CE certification
• Sourcing of prototypes