I believe that in most scenarios it is ideal for the risk management team to be made up with members of the project team and those that belong to the risk management department. The individuals that are on the project…   Read more»

I believe risk acceptance and its effect(s) are directly tied to the quality of the risk assessment itself, which also affects the form of a response to the hazard. When risk assessment is conducted, there is an order of precedence…   Read more»

Certain risks in medical device development can be mitigated but not eliminated. After the risk management plan is executed, the risk management team must measure the effectiveness of their plan. Residual risk refers to the remaining risk after strategies have…   Read more»

During my time as a co-op at GAF, I have witnessed a variety of hazards that had to be mitigated, mostly within the R&D labs. Each of the labs had a variety of equipment with varying levels of risk. One…   Read more»

The reason these standards cost money is because organizations like ISO and ASTM are non-profit bodies that fund their operations through the sale of their standards. They invest a lot of time and expertise into developing and maintaining them, often…   Read more»

I completely agree with your point about the importance of risk management assessments for medical devices. They really are essential for identifying and mitigating potential hazards before a product reaches users and patients. While the process can be time-consuming and…   Read more»

A real life scenario of hazardous material causing significant harm would be in 2004 at the Centers for Disease Control and Prevention (CDC), where a serious lab safety breach took place. The hazard involved the bacterium Bacillus anthracis, which causes…   Read more»

The key to determining whether a risk is truly worthwhile lies in evaluating how integral that risk is to the product’s intended use. However, it is crucial to strike a balance between ethical responsibility and technological progress. For example, in…   Read more»

I think everyone made really strong points about environmental conditions, user error, and maintenance being major risk factors for AEDs. I would like to introduce the additional risk of patient-specific failure in electro-pad adhesion. For example, excessive body hair, sweat,…   Read more»

As many users of this post have said, biotechnology companies tend to look at the rewards more than the risks. I do think that there are some companies that actually do take into account the risks, but they only take…   Read more»

There are some cases where the risk management team is the project team. From my experience from my undergraduate senior project, my project team was the risk management team because it was our project. We knew the project all the…   Read more»

As we have learned from this week’s lecture, hazards are a potential problem posed to you. It is just there and it does not do anything to you. These can include biohazard, chemical, electrical, or mechanical hazards. A hazardous situation…   Read more»

I really appreciate how many of you emphasized that the success of risk management ultimately depends not just on structure, but on how all participants are invited to engage. Personally, I believe that the combination of preparation, rotating facilitators, and…   Read more»

Risk management, in my opinion, is an essential component of the planning stage of any project or product development. Organizations can avoid costly mistakes later on by developing methods to reduce or prevent unfavorable effects by detecting potential risks early…   Read more»

A laboratory setting provides a vivid illustration of a hazard in a hazardous condition. Let’s say GenBio Labs, a biotech business, is developing vaccines using bacterial cultures. The existence of a pathogenic strain of E. coli is one of the…   Read more»

A device’s safety and dependability can be greatly improved by implementing a risk management assessment. Manufacturers can avoid malfunctions or injuries that may arise from device failures by recognizing possible dangers early in the design or production process. This proactive…   Read more»