Join us for an intensive 1-day training on ISO 14971, the global standard for medical device risk management. This course is specifically designed for medical device manufacturers developing Software as a Medical Device (SaMD) or Software in a Medical Device (SiMD) and will cover how to integrate risk management throughout the software life cycle.
What You’ll Learn:
- ISO 14971 Fundamentals: Risk management framework and regulatory expectations
- Risk Management for SaMD & SiMD: Identifying, evaluating, and mitigating software-related risks
- Cybersecurity & IEC 81001-5-1 Compliance:Understanding IT security considerations in the software development life cycle
- Real-World Case Studies & Practical Application:Interactive discussions and examples from the industry
Course Format:
Full-Day Training spread over 2 days from 11am – 3 pm: Theory, risk analysis techniques, and hands-on case studies tailored to SaMD & SiMD
This course is ideal for quality, regulatory, engineering, software development, and risk management professionals working in the medical device industry.
