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

Quality and RegulatoryDuration
EN ISO 13485:2016, Basic Course

2 days

Internal audits based on ISO 19011 and ISO 134852 day
Quality System Regulation, 21CFR8201 day
FDA inspection preparations 1/2 day
Risk Management for Medical Devices2 days
Software Risk management for Medical Device software2 day
Cybersecurity risk management for Medical Devices 1 day
Design control1 day
Medical Device software validation in compliance with IEC 623042 days
Clinical Evaluation 1/2 day
Usability according to IEC 623661/2 day
IEC/ISO 80001 – Application of Risk Management for IT-networks1 day
EU Medical Device Regulation Course
MDD to MDR – Key changes and implementation. Prepare your organization for the transition
1 day
… IVDR and more to come. Just ask, we are constantly developing the portfolio.

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