Products
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SYS-031: EO Sterilization Validation Procedure
CourseThe updated procedure defines the requirements for ethylene oxide (EO) sterilization validation and revalidation/requalification outsourced to a contract sterilizer.
$299
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SYS-032: Identification and Traceability Procedure
CourseOur identification and traceability procedure meets two requirements in ISO 13485:2016 (i.e. Clause 7.5.8 and Clause 7.5.9).
$299
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SYS-033: Receiving Inspection Procedure
CourseThe purpose of this procedure is to define the requirements for conducting receiving inspection of finished devices, sub-assemblies and components.
$299
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SYS-038: Controlled Environment Gowning Procedure
CourseThe purpose of this procedure is to ensure your company’s requirements for cleanroom gowning are met by describing how to apply barrier clothing before entering the cleanroom.
$299
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SYS-039: UDI Requirements Procedure
CourseThis training includes our procedure for UDI Requirements and the FDA template for the GUDID data elements. We also provide a 10-question quiz on the FDA's UDI requirements and a training certificate when you complete the quiz.
$299
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SYS-041: Clinical Evaluation Procedure
CourseThis procedure and webinar bundle includes requirements for European MDR (Regulation 2017/745) and MDCG guidance documents.
$299