Trainings
Trainings
To stay Competent
Having a good understanding of the medical device regulations & harmonized standards is a must for every medical device organization and its staff. At 8C Healthcare, we provide overview sessions and hands-on-trainings for on the following medical device topics.
- ISO 13485 - Quality Management System
- ISO 14971 – Risk Management Design Controls
- Design Controls
- IEC 62304 – Software Development Lifecycle
- IEC 62366 – Usability Engineering/Human Factors
- IEC 60601 – Electrical Safety
- EU MDR & IVDR
- US FDA Regulatory Pathways
