Risk Management
Risk management is a product lifecycle process with most of the activity taking place during the design and development process. The hazards and assocated risks are determined. Where thoses risks are unacceptable, risk controls in the form of design features, alarms or warnings are implemented to mitigate the risk. Smestad & Associates expertise can help your company establish and implement a risk management program to meet EN ISO 14971 including the following:
- Risk Management Plans and Reports
- Risk Analysis
- Failure Modes & Effects Analysis (FMEA)
- Fault Tree Analysis (FTA)
- Conduct Audits of Risk Managment Process