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SYS-042: Canadian Licensing Procedure

Course

The Canadian Licensing procedure sets out requirements for submitting and maintaining Canadian Medical Device Distribution Licenses under the Canadian Medical Device Regulations and meets the applicable regulatory requirements for Canadian Licensing.

SYS-043: Steam Sterilization Validation Procedure

Course

This procedure is to define the requirements for steam sterilization validation using the overkill method as defined in Annex D of ISO 17665-1:2006 (R2013).

SYS-046: Packaging Validation Procedure

Course

SYS-047: Gamma Sterilization Validation Procedure

Course

SYS-049: Communication with Competent Authorities, Notified Bodies, & Economic Operators

Course

This procedure meets the requirements for communication with economic operators in the new EU MDR (i.e. Articles 10-15, and 30).

SYS-052: Translation Procedure

Course

This training includes our procedure and forms for translation of labeling and IFUs.