ISO 13485


1. Explanation of basic terms and concepts in Medical Devices 13485 Standard

2. Detailed explanation of all substances in ISO 13485 Standard

3. Risk Assessment

4. System documentation requirements

4.Exercise and practical work

5.Information on certification, certification and accreditation

Who can participate?

All employees wishing to set up and maintain a management system for ISO 13485 Medical Devices
University Graduates

Education time:

2 days (16 hours)

Educator Feature:

40 hours of head auditor training on the relevant standard and 35 man / day audited completed auditor