I think a good way to decided what levels of residual risk is acceptable is to create a quantifiable way to measure it, instead of leaving it up to opinions. The scale would make it clearer for how often the…   Read more»

I definitely believe risk management is an important part of the planning phase. It’s not a waste of money or time. In fact, it often saves both in the long run. Identifying potential risks early helps teams prepare for what…   Read more»

It’s important to look at hazards and hazardous situations separately because they happen at different stages of risk. A hazard is something that can cause harm, while a hazardous situation is when someone is actually exposed to that hazard. By…   Read more»

A real example of this happened during the 2014 Ebola outbreak, when healthcare workers in West Africa faced serious exposure risks. The hazard was the Ebola virus present in infected patients’ blood and bodily fluids. The hazardous situation occurred when…   Read more»

I think risk acceptance means recognizing a risk but choosing not to take any immediate action because the potential impact is minor or the cost of controlling it is too high compared to the benefit. I don’t think accepting a…   Read more»

Risk acceptance does not lead to a higher probability of risk. When you are accepting a risk, it means that the team has done all they can to mitigate the risk. There comes a point where the team can’t mitigate…   Read more»

I have used FMEA before in my role as Mission Assurance Specialist for a NASA Workforce Development Program. I find it very helpful when doing risk assessments because it has all the necessary information you need to effectively evaluate the…   Read more»

As part of my job, I am required to attend various safety training sessions to use different equipment. As part of Radiation Safety Training, I heard the importance of covering any radioactive material that you are working with, once you…   Read more»

When it comes to meeting minutes, they are extremely important in the process of everything when it comes to the development of everything especially medical devices. The reason why they are important is because it the most vital time when…   Read more»

What contributed to the Therac-25 incidents was a reliance on old code as mentioned in previous posts. Engineers possibly assumed their code from previous projects was fine as is. With AI entering medical devices now, what is stopping engineers from…   Read more»

A contract manufacturer (CM) plays a vital role in process in which validation and the responsibilities with the executing of the validation plan. With the validating multiple pieces of equipment and establishing a preventative maintenance plan for it as well….   Read more»

Everyone’s shared great technical solutions, but another issue behind documentation fatigue is how people interact with the process, not just the tools themselves. When updates feel like busywork instead of part of the project’s story, engagement drops.   Organizations could…   Read more»

Everyone’s made great points about prediction limits and company oversight. Another major gap is that verification and validation don’t really reflect real-life patient diversity. The DePuy implants may have passed lab tests, but they didn’t consider how factors like bone…   Read more»

While many have raised valid points about adaptive algorithms and overconfidence in structured systems, I think a modern “Therac moment” could result less from technical gaps and more from ethical and organizational blind spots. Current design controls ensure functional safety,…   Read more»

Following design controls intentionally is important for efficiency, even if it feels like it’s there just for compliance. A lot of it feels like regulatory checkboxes, but it can benefit a project team if it is followed. In business, there…   Read more»

I do believe that the four columns of input, specification, verification, and validation are always enough for a complete Design Matrix. I do feel how ever though that it would necessary to add a column to it of the way…   Read more»

As briefly mentioned, sectioning off the DDP by “departments” will allow the file to be filtered to view what is relevant to an individual or team. Filtering changes based on the specific sector the change came from allows the document…   Read more»

Whether or not a company utilizes design controls as a tool or a checkbox ultimately comes down to their internal culture and the overall attitude within. Companies, whether big or small, that value accountability, learning, and growth will naturally treat…   Read more»

I think balance really can come down to defining the purpose for each document tier. Perhaps removing informal working logs or notebooks that are not officially updated changes in the DDP (such as design changes that affect verification, validation or…   Read more»

Some examples of device changes that need to be controlled are updates to the materials used, switching suppliers, or adjusting a device’s size or shape. Even small changes like replacing adhesives, updating sterilization methods, or modifying software code can affect…   Read more»