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OEM・ODM

Contracted development and manufacturing services

スライドイメージ

Available phases

We support partner companies through high-quality and highly reliable production under a quality management system compliant to ISO 13485.
With a consistent support system from planning and designing to manufacturing and launching, we flexibly meet various developmental needs.
  • Product planning/specification review
     We support product concept planning with consideration of the clinical environment, market needs, and regulatory perspectives.
  • Design and development
    Our ISO 13485-compliant design control process ensures safe and effective product delivery.
  • Pilot production/verification
    We can manufacture prototypes taking into consideration their use in actual medical practice and provide various performance and safety tests.
  • Manufacturing/post-launch support
    We offer services including OEM manufacturing and scale-up, as well as support for post-launch quality control and continuous improvement.

製品の仕様

Case examples

  • Case 1: 
    Contracted manufacturing (sterilization) of single-use laser probes
    Validation of ethylene oxide gas sterilization based on ISO 11135
  • Case 2:
     From the design to the launch of thin endoscopes for peritoneal dialysis
    From designing, taking regulatory approval/certification into consideration, to the acquisition of regulatory approvals

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医療従事者

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医療担当
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臨床奇技師、臨床工学
技士、歯科技工士その他の医療担当者の総称
医療業務関係者
医療機関等の役員、従業員、その他当該医療機関等において医療機器の選択又は購入に関与する者
医療担当者等
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