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 firstname.lastname@example.org.
Quality and Regulatory
EN ISO 13485:2016, Basic Course
Internal audits based on ISO 19011 and ISO 13485
Quality System Regulation, 21CFR820
FDA inspection preparations
CE marking of Medical Devices
Risk Management for Medical Devices
Software Risk management for Medical Device software
Cybersecurity risk management for Medical Devices
Medical Device software validation in compliance with IEC 62304
Usability according to IEC 62366
IEC/ISO 80001 – Application of Risk Management for IT-networks
EU Medical Device Regulation Course
MDD to MDR – Key changes and implementation. Prepare your organization for the transition
… 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