Unannounced Audits

This course is designed to provide participants with an understanding of the risk classification criteria for medical devices of the EU Medical Devices Directives, to prepare medical device organizations to unannounced audits. 


Gain an understanding of the reclassification of new and/or existing medical devices according to the classification criteria of EU Medical Devices Directives. The course will provide the tools to medical device organizations to undergo unannounced audits 

Inteded Audience

  • The course is especially designed for medical device manufacturers and all the personnel involved in design and classification of medical devices (QA, DD, RA etc.)
  • All those that are involved in the unannounced audits (AQ,RA,etc.)
  • Regulatory, quality, design, development, manufacturing, marketing managers and personnel.


Participants should have experience with or basic knowledge of quality management systems for the medical device industry. Recommended is a basic awareness of medical devices, quality assurance, and ISO 13485.

Request an in-company training quote

We can deliver training at your premises, providing a cost effective way of training a larger group.

Request an in-company training quote

Training Flyer

Unannounced Audits training flyer