The course helps you to understand the requirements of ISO 13485 and to apply them as an auditor. In short and varied sessions, you will gain the necessary knowledge about audits. You will learn how to implement them in workshops and role plays.
1. Day 20.08. 9-17 Uhr 2. Day 21.08. 9-17 Uhr 3. Day 27.08. 9-17 Uhr 4. Day 28.08. 9-17 Uhr 5. Day 29.08. 9-17 Uhr
During the course, you will learn to
At the end of the week and upon passing an examination, you will receive a certificate attesting to your newly acquired knowledge and capabilities. The examination takes place online and is conducted by an independent, accredited organization. You will have two hours to answer 75 multiple-choice questions on complex scenarios. The exam fee is included in the seminar price.
The course is suitable for people who wish to carry out audits of quality management systems in accordance with ISO 13485 and obtain certification. Typical course participants are (future) quality managers at medical device manufacturers and service providers, as well as employees at notified bodies.
You can find the exact learning content as well as the schedule of the seminar in the agenda: