M
Hi
There are numerous references in ISO 13485:2003 detailing provisional requirements contingent on national or regional regulations, including for example:
6.2.2 Note - National or regional regulations might require the organization to establish documented procedures for identifying training needs
8.1 NOTE - National or regional regulations might require documented procedures for implementation and control of the application of statistical techniques
8.5.1 If national or regional regulations require notification of adverse events that meet specified reporting criteria, the organization shall establish documented procedures to such notification to regulatory authorities.
I would be obliged if anybody can provide examples such national or regional regulations.
Many thanks
Mike Caudwell
There are numerous references in ISO 13485:2003 detailing provisional requirements contingent on national or regional regulations, including for example:
6.2.2 Note - National or regional regulations might require the organization to establish documented procedures for identifying training needs
8.1 NOTE - National or regional regulations might require documented procedures for implementation and control of the application of statistical techniques
8.5.1 If national or regional regulations require notification of adverse events that meet specified reporting criteria, the organization shall establish documented procedures to such notification to regulatory authorities.
I would be obliged if anybody can provide examples such national or regional regulations.
Many thanks
Mike Caudwell
