We are providing trainings in following areas:
- Management systems
- Quality management system (ISO 9001)
- Information security management system (ISO/IEC 27001)
- Quality management system for medical devices (ISO 13485)
- Environmental management systems (ISO 14001)
- Occupational health and safety management systems (ISO 45001)
- Risk management for all the management systems, and risk management as a general topic (according to ISO 31000)
- Process approach
- Trainings regarding medical devices
- Requirements of Medical devices regulation (EU) 2017/745 (MDR) regarding manufacturer’s quality management system
- Person responsible for regulatory compliance (PRRC)
- Preparation of technical documentation
- Post-market surveillance and post-market clinical follow-up
- Biological evaluation: planning and conducting
- Risk management according to EN ISO 14971:2019 + A11:2021 and MDR
- Unique device identifier (UDI) system
- Registration of economic operators and medical devices in EUDAMED database
All trainings can be conducted on premises of the client or online.