Does the product's design history identify the risk created by adding the treated material?
Last reviewed: .
Does the product's design history identify the risk created by adding the treated material?
The Terms of Use state that a test of C-POLAR material, a component, or a prototype does not establish the performance of a finished product that incorporates it, and that construction, processing, storage, wear, cleaning, other components, and actual use may change the result.
A design history file belongs to the manufacturer that opened it, and C-POLAR holds none. The Terms of Use state: “A prospective partner or manufacturer must perform its own testing, validation, compatibility work, safety review, risk review, and quality controls for its proposed product and use.” They also state: “Use evidence, specifications, instructions, and warnings specific to the actual finished product and use.” The Medical devices chapter describes a Research Application, and it does not describe a finished product currently available from C-POLAR for that use.
Source: C-POLAR — Terms of Use, sections 3, 4 and 5, https://cpolar.tech/terms/.
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