I think everyone here did a good job at breaking down the conceptual difference between hazards and hazardous situations. Something new I have to add is how time and device evolution should not blur the line between the two as…   Read more»

I like how everyone emphasized how important structure, preparation, and inclusion is in risk management meetings. I want to talk more about the format of a meeting itself that can influence risk visibility. Dr. Simon talked about how risk management…   Read more»

Everyone has brought up excellent points about Poka-Yoke and how it reduces errors on the production floor. However, something that no one has touched on yet is how Poka-Yoke can bridge the gap between manufacturing and compliance. Dr. Simon talks…   Read more»

Implementing a risk management device assessment for medical device helps identify potential hazards early, reducing the chance of device failure or patient harm. A clear risk management plan outlines which risks are acceptance and how will be handled, making the…   Read more»

As an example of a hazard in would be electrical hazard in a hospital can occur when a patient monitoring device has a faulty power cable.  the hazard is the damage cable itself . The hazardous situation happens when the…   Read more»

Risk management is a controlled process to identify and reduce potential hazards in medical devices. It ensures product safety. Medical devices companies are responsible for managing risks because it protects patients and prevents costly failures. It also helps decide whether…   Read more»

In past projects, I’ve primarily used Failure Mode and Effects Analysis (FMEA) because it provides a structured and quantitative way to assess potential risks. By breaking down each step of a process or component function, FMEA helps identify possible failure…   Read more»

I agree with your explanation — distinguishing between hazards and hazardous situations is essential because it helps clarify when and how a potential danger actually becomes a risk. A hazard on its own may not always lead to harm unless…   Read more»

I agree with your stance that risk avoidance tends to be the most favored approach in manufacturing, particularly because it directly supports safety, efficiency, and regulatory compliance. In manufacturing, risk management is deeply integrated into process design and quality control…   Read more»

I think documentation of each potential risk found and measures to deal with it, whether it be avoidance or mitigation. It’s important that if a risk it found, there’s no way for it to appear frequently once the product reaches…   Read more»

I think the distinction is important because they happen at different stages, and thus must be managed differently. Hazards are managed by prevention to stop the danger from ever happening in the first place. That’s why regular maintenance is usually…   Read more»

In past projects, I’ve used brainstorming and the Failure Mode and Effects Analysis (FMEA) method the most. Brainstorming is great for quickly generating ideas and identifying possible risks from different perspectives, but I find FMEA to be the most beneficial…   Read more»

At my previous internship, I learned how easily hazards can turn into serious situations if not managed properly. For example, imagine working at a company called MedTech Labs that develops diagnostic equipment. During testing, a technician accidentally spills a sample…   Read more»

I definitely believe risk management is an essential part of the planning phase. It’s not a waste of time or money; it’s actually a smart investment that can prevent much bigger losses later on. By identifying potential risks early, teams…   Read more»

I think many companies initially treat design controls as a regulatory checkbox, especially smaller startups rushing toward 510(k) or PMA submission. However, the organizations that truly excel in product quality recognize that design controls are not barriers but rather they…   Read more»

Organizations can balance the need for up-to-date documentation with efficiency by adopting a structured, tiered approach to document management. Core documents like the Design and Development Plan (DDP) should be continuously updated only for significant design changes, while minor updates…   Read more»

The best way to translate a qualitative user need into a quantitative and testable design input is through iterative analysis and measurable criteria definition. The design team should first study the user’s intent behind the qualitative statement—for example, “easy to…   Read more»

While modern design control systems like ISO 13485, IEC 62304, and FDA 21 CFR 820 are far stronger than those in the Therac-25 era—mandating rigorous verification, risk management, and traceability—they are not yet fully equipped to handle the complexities of…   Read more»

I would argue that structured frameworks are the only reliable way to bridge user needs with design inputs. Translating a qualitative statement like “easy to use” or “comfortable to wear” into measurable engineering terms requires more than experience or assumption;…   Read more»

AI driven and adaptive algorithms in medical devices introduce a new layer of uncertainty. Unlike deterministic systems, machine learning models can behave unpredictably outside trained data sets. Verification methods for such systems are still evolving, and traditional validation approaches may…   Read more»