AUDIT
Clinical Investigation Audit
Training: ISO 13485/QSR 21 CFR 820
Supplementary training and education are often overlooked by medical device professionals until it is triggered by an upcoming FDA or Notified Body and/or ISO 13485 certification audit. The requirement for training is, nevertheless, an essential element of all Quality Management Systems, and should not be confined to only those occasions. We offer a wide range of training courses, below you will find all courses concerning the ISO 13485 and the QSR.
Course: introduction to ISO 13485 - A Global overview
The one day course Introduction to ISO 13485, Medical Devices - Quality Management Systems-Requirements for Regulatory Purposes, provides an insight in the use of the Standard as basis for a Quality Management System for Medical Device manufacturers. Read more
Training: QSR 21 CFR 820
The one day course Introduction to ISO 13485, Medical Devices - Quality Management Systems-Requirements for Regulatory Purposes, provides an insight in the use of the Standard as basis for a Quality Management System for Medical Device manufacturers. Read more