Design & Development of the medical device ——OEM & Development partner

Design & Development of the medical device ——OEM & Development partner

We have advantages on sales and development of medical device in medical industry and can develop medical device to meet various needs. We will supply safe products and support launch of co- and self-developed products.

  • 01Design process

    Designing 2D or 3D drawings and planning processes compliant with QMS and ISO.

  • 02Suggestion of various moldings
    • InjectionGeneral molding, insert molding and two colors of molding etc.
    • ExtrudingSingle lumen, a heteromorphic tube, tube with line etc. These products can be made from various materials
    • BlowDirect・injection blow
  • 03Example of development cooperation (Assembly)
    • Assembly, connection or gluing by hand work
    • Micro and precision processing such as catheters
    • Metal processing
    • Processing with automatic machines or semi-automatic machines.
    • Processing with high frequency welder and ultrasonic welder.
    • Processing with UV adhesive.

    If necessary, we suggest process validation.

  • 04Sterilization contract
    • Ethylene oxide gas sterilization
    • Gamma-sterilization
    • Electron beam sterilization
    • Proposal of suitable sterilization method for your products.

    Proposal of protocol compliant with ISO14971.

  • 05Packaging design

    We suggest process validation such as various sterilization methods and package design, heat seal validation according to purpose.

  • 06Product example (Medical device)
    • Products with injection needles.
    • Various disposable products with PVC tubes
    • Processing catheter tip
    • Product assembled resin with UV adhesive
    • Bag with high frequency welder.
    • Ultrasonic welded products.
    • Printing scale to a catheter
    • Combination medical device with pharmaceutical products

Physical Property Testing Support

Various and one-off examinations can be performed. We have an autograph, a constant-temperature oven, and a projector.
Example) Slide examination, pulling, compression, acceleration examination or dimensional measurement of the syringe.
※A separate fee is required for these tests.

OEM Developed Product

We design and develop medical device and its component. We select the most suitable manufacturer and can reduce your cost of development.