(i) Electrical Safety Test (based on IEC 60601-1, 62353 & 61010-1)
(ii) Safety in Healthcare
(iii) Safety for Equipment
(iv) Introduction Risk Management in Medical Device ISO 14971
- Identifying hazards and hazardous conditions associated with a medical device that could place patients or healthcare workers at risk.
- Estimating the potential occurrence of such risks, and evaluating the extent of the consequences.
- Developing and implementing active safeguards within the device or the production process to control risks.
- Regularly reviewing and monitoring the process to assess the effectiveness of risk management