Seminare USA
AQL- Statistical Methods according to ISO 3951-1 and ISO 2859-1
Benefits of IEC 80001-1 compliant Medical IT Networks
Clinical Evaluation - Clinical Studies
Development and Validation of Medical Software according to IEC 62304
Development and Verification of ME Devices and Systems according to IEC 60601-1, 3rd Edition
European Requirements for Medical Devices
Quality Management according to ISO 13485 and 21 CFR 820 QSR
Regulatory Requirements for Medical Devices in EU and USA
Risk Management according to ISO 14971:2007
Usability according to IEC 62366 and IEC 60601-1-6
Usability for Medical Software
Validation of processes and deployed Process Software