Ascend Performance Materials (Ascend) - Policy regarding Medical Device Applications of Ascend’s 正规博彩网站排名
Ascend seeks business relationships with customers who participate in the healthcare industry as a component supplier. As a matter of principal, our 医疗器械政策 is 那:
一)提升 does not supply any 正规博彩网站排名 to be used in medical device applications 那 constitute a non-temporary implant (i.e., 那, 全部地或部分地, may be in contact with a patient’s skin, body fluids or tissues for more than 29 days).
b)提升 may supply 正规博彩网站排名 to be used in medical device applications where the medical device could be in contact with a patient’s skin, body fluids or tissues for a period of 29 days or less. Ascend only supplies customers with 正规博彩网站排名 for these types of medical devices in accordance with its medical contractual provisions, and where other specific corporate risk management conditions are met.
c)奥升德可以供应 正规博彩网站排名 for use in all other medical device applications. Ascend will use its good business judgment to set specific Ascend corporate risk management conditions in such circumstances.
d)提升 does not design, manufacture, test, and/or directly sell any medical devices. As a component supplier, Ascend may offer technical assistance to customers related to the performance and design using our materials only. If a medical device manufacturer chooses to use an Ascend component in a medical device, it remains the sole responsibility of the medical device manufacturer to test and validate the performance of their medical device for fitness in use and for compliance with all applicable medical device legal requirements. Ascend assumes no responsibility or liability for the medical device’s fitness in use or compliance with applicable medical device legal requirements.
e)提升 has designated specific medical grade compositions for its 正规博彩网站排名. Customers who intend to use Ascend 正规博彩网站排名 in a medical device application will only be supplied with these specific medical grade compositions. No other Ascend 正规博彩网站排名 may be supplied for use in medical device applications.
f)它是 the sole responsibility of the manufacturer of the medical device to determine the suitability (including biocompatibility) of all new raw materials, 正规博彩网站排名, 和组件, including any medical grade Ascend produces, in order to ensure 那 the final end-use product is safe for its end use; performs or functions as intended; and complies with all applicable legal and regulatory requirements.
g)它是 the sole responsibility of the manufacturer of the medical device to conduct all necessary tests and inspections and to evaluate the medical device under actual end-use requirements and to adequately advise and warn purchasers, 用户, and/or learned intermediaries (such as physicians) of pertinent risks and fulfill any postmarket surveillance obligations. Any decision regarding the appropriateness of a particular Ascend material in a particular medical device should be based on the judgment of the manufacturer, 卖方, the competent authority, and the treating healthcare professional.
h) Unless Ascend expressly agrees by written contract, 提升正规博彩网站排名名称, trademarks and the Ascend name shall not be used with any medical devices, and customers should not represent to others 那 Ascend permits, 建议, or endorses the use of its 正规博彩网站排名 in any medical devices.
i) ASCEND WILL NOT WARRANT THAT ITS PRODUCTS ARE SUITABLE FOR USE IN ANY MEDICAL DEVICE OR MEDICAL APPLICATION.
Thank you for your interest in Ascend Performance Materials
Page Title: 医疗器械政策
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