SYS-032 Identification and Traceability

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his procedure applies to testing samples, raw materials, in-process sub-assemblies and finished devices. Certain implants may fall under the requirement for Implant Registry Cards by Health Canada, but this is not included in the scope of this procedure. This procedure is the primary document meeting the applicable regulatory requirements for identification and traceability as defined in your company’s Quality System Manual (POL-001).