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Risk-management Policy

Kaneko MediX, Inc. Risk Management Policy

Basic Policy

Basic Policy

 Kaneko MediX, Inc., as a manufacturer of various medical injection needles, has a basic policy of carrying out product realization activities with product safety as the highest priority.

Activity Policy

 The medical injection needles we manufacture are mainly used for puncturing the human body, especially veins and arteries that come into direct contact with blood, and inevitably manufacture high-risk products.
 For use in the medical field, qualifications are certified in accordance with the related regulations "Risk Management Regulations" (KES-01-031) regarding legal regulations, presumed accidents and risks, as well as the requirements of domestic and overseas customers who are the supply destinations. Appropriately apply the legal requirements of each country or region by the person, identify the hazards related to various medical injection needles manufactured by our company, analyze, evaluate and control the risk, and evaluate the effectiveness of the control. Our policy is to establish and maintain a series of monitoring processes and to realize products that give top priority to product safety.Plan activities and review results as necessary to ensure that the risk management process continues appropriately and effectively.These are documented in a risk management file and conformity is recognized by examining the file.
 The following criteria are used as criteria for accepting risks.
 1) Strict adherence to the safety level required by regulations in Japan and overseas shipping destination countries.
 2) Establish international standards, customers, regional / country standards that are appropriately applied to products, and are required by those standards.
  Strictly adhere to the safety level.
 3) Adoption of safety measures that are generally used in our existing products and similar products of other companies at the same level.
 4) Adoption of safety measures that are widely known in the literature and conference presentations.
 5) Completion of risk management in accordance with documented internal procedures and ISO 14971: 2007.

Kaneko MediX, Inc.
President Takeyoshi Sakashita
2008/6/19

Kaneko MediX, Inc.
329-2703
Tochigi Prefecture, Nasushiobara City, Tsukinukizawa 342-17
TEL. 0287-36-6688
FAX: 0287-36-5827

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Manufacturing of medical injection needles
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