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 RegulatoryDuration
CE-marking1 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 Devices2 days
Medical Device software process development based on IEC 623042 days
Clinical Evaluation 1/2 day
Cybersecurity risk management for Medical Devices 1 day
Design control1 day
FDA inspection preparations 1/2 day
Internal audits based on ISO 19011 and ISO 134852 day
Quality System Regulation, 21CFR8201 day
Usability according to IEC 623661/2 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