Training Programs
We offer on and offsite training for all aspects of Medical Device Quality and Regulatory processes
EU MDR / IVDR
Risk Management
ISO 13485/QSR
MDSAP
Clinical Evaluation
Post Market Surveillance
Tissues of Animal Origin (EU 722/2012, ISO 22442 Series)
Packaging and Shelf-Life
Performance Evaluation (analytical performance, clinical performance, scientific validity)
Software Validation (SaMD, MDSW)