OEM Manufacturing Capabilities

Trays

Materials

Aluminum

• Lightweight
• Higher durability than plastic
  

  IN-8620 Olympus® Endoeye® Laparoscope HD

• Greater thermal conductive properties than other materials

Stainless Steel

• Withstands high pH washing and disinfecting
• Higher durability than other materials

Color Options

Color Anodization

• Available on entire tray or individual base and cover with aluminum

Dimensions

• Existing stock sheet metal is available in a variety of sizes
• New sheet metal can be created for specific needs

Laser Engraved Plaque

Labeling/Marking

• Custom labeling
• Part number
• Branding and logo artwork
• Available in digital or screen printed
• IFU/Product Supplement
  • Created to match instrument validations with existing tray 510(k)s
    

    Plaque with Insturment Layout

• Anodized Logos/Branding
  • Available with aluminum sheet metal
• Screen Printing
  • Available on both aluminum and stainless steel sheet metal
• Pad Printing
  • Available on both aluminum and stainless steel sheet metal
• Laser Engraving
  • Available on anodized aluminum
• Laser Annealing
  • Available on stainless steel

Internal Components

• Customized Components
  • Design components to optimize layout and design
  • New molds specific for instrumentation
  • Water jet cut blanks specific for instrumentation
  • Molded holders made to specification
• Standard Components
  • Over 200 pre-designed parts
  • Dividers, posts, small parts organizers
  • Medical Grade Silicone (blue or black colors available)
  • Water jet cut silicone holders for increased utilization

Packaging

• Custom foam inserts for maximum protection during shipping
• Box labeling can be created with company logo, branding and technical specifications
• Individual or bulk packaging options

Engineering + Regulatory

Example of a 3D model

Quality

• Sterilization validation and feasibility testing coordination
• FDA 510(k) clearances
• FDA Registered
• ISO 13485:2003 and NF EN ISO 13485:2012 Certified
• CE Certificate
• Early Release Prototypes
• Production equivalent assemblies for review, testing, and fit verification

Documentation

• SOLIDWORKS 3D modeling + rendering
• Technical drawings
• Tray Designs