YT Global Precision Leader Ltd

Risk management of medical device

Medical device risk refers to the combination of the probability of medical device damage and the severity of medical device damage. Risk management can be an integral part of the quality management system, or it can be established separately. The risk may be related not only to the loss of the patient, but also to the loss of the user and other persons, and the damage of property (such as items, data, and other equipment) or the environment. Due to the diversity of stakeholders, including healthcare workers, healthcare organizations, governments, industry, patients, and the public, the concept of risk management is particularly important for medical devices. It is generally accepted that the concept of risk has two key points:

- Probability of injury

- The consequences of the injury (severity)

The training contains following 8 points:

1.  Terminology and basic risk concepts

2.  Requirements for risk management systems

3.  Risk analysis, the process of analysis

4.  Risk evaluation

5.  Risk control includes the implementation of control schemes and control implementation

6.  Comprehensive residual risk evaluation

7.  Risk management

8.  Production and post-production activities include the collection of information, review and take actions 

The training provides manufacturers with a framework for systematically applying experience, insight, and judgment to manage the risks associated with the use of medical devices. Clarify the awareness of the whole product and process of risk management, and effectively implement risk management activities in the whole life cycle of product planning, research and development, production, and post-production.