Customized training courses and seminars
We provide training courses and seminars in the following areas, both as open courses/seminars and as customer site specific courses/seminars. We can sometimes customize the courses or combine, as seminars, half day courses or one-day courses.
Please contact us for a discussion, content specification or proposal at academy@qadvis.com.
| Quality and Regulatory | Duration |
|---|---|
| CE-marking | 1 day |
| EU In Vitro Diagnostic Regulation Course (IVDR) IVDD to IVDR – Key changes and implementation Prepare your organization for the transition | 1 day |
| EU Medical Device Regulation Course (MDR) MDD to MDR – Key changes and implementation Prepare your organization for the transition | 1 day |
| EN ISO 13485:2016, Basic Course |
2 days |
| Risk Management for Medical Devices | 2 days |
| Medical Device software process development based on IEC 62304 | 2 days |
| Clinical Evaluation | 1/2 day |
| Cybersecurity risk management for Medical Devices | 1 day |
| Design control | 1 day |
| FDA inspection preparations | 1/2 day |
| Internal audits based on ISO 19011 and ISO 13485 | 2 day |
| Quality System Regulation, 21CFR820 | 1 day |
| Usability according to IEC 62366 | 1/2 day |
Our courses are most often conducted by the experts involved in the development of the standard and the course also focus on practical issues what manufacturers and suppliers need or should to do based on our hands-on experience from the medical device industry.
Contact me for further information
Robert Ginsberg
Office +46 8 621 01 05 or send me an mail
