ISO 13485:2016 Standard & Internal Auditor Training Bundle

This eLearning course aims to familiarise you with the auditing management systems guidelines in accordance with ISO 19011:2018.

MDR The MDR was published in the EU official Journal on the 5th May 2017, formally coming into force on the 25th May 2017. The MDR becomes fully applicable after a 3-year transition period on 26th May 2020. The MDR is now in its transition phase, at the end of which the current legislation of the Medical Devices Directive 93/42/EEC will be repealed and no longer apply in the EU. In the transition period, a device could be CE Marked under either the current Directive or the new Regulation, dependant on the designation of Notified Bodies to the new Regulation and expiry date of certificates under the Directive. Please see the Medical Device Regulation Implementation Training Course (EU) 2017/745 Synopsis for a more comprehensive overview of this course and to review any pre-course requirements that may apply.