ISO 13485. Quality Management Systems for Medical Device Producers.
Development and Implementation of Quality Management System according to ISO 13485. Internal audit
Risk Management according to ISO 14971. Integration into a quality management system
Medical Device Clinical Studies according to ISO 14155
Technical files for MDD, IVD, CMDR & JPAL
International Regulatory Affairs Manager. Practice of Medical Device Product Launch Implementation in EU, Canada, USA. Directives, compliance assessment.