This one-day course will provide an overview/understanding of the ISO 14971:2013 standard and its relationship to a Quality Management System and regulatory requirements for the Medical Devices/IVD Industry.
The running example will be used throughout the five-day Risk Management and Analysis in Medical Device Manufacturing Series. (This also includes:Practical Risk Management using DFMEA and Practical Risk Management using PFMEA).
Who Should Attend
- Risk Management personnel
- Quality Managers
- Technical Managers
- Regulatory Affairs Managers
Recommended Training and/or Experience
Participants should possess a working knowledge of quality systems and methodologies.
Each participant will receive a seminar manual including breakout exercises and related material.
- Understand the key elements required for the management of risk as specified in ISO 14971:2009
- Understand the relationship between risk management and regulatory requirements.
- Understand the relationship between risk management and quality management system requirements.
- Have experience of constructing a risk analysis and risk evaluation in a workshop environment
- Risk Management
- Managing Risks
- Risk Analysis