That’s a really good point about catching design issues early and I actually can relate. From my experience during my internship, I’ve seen how important proper documentation is, even though it can feel time consuming. I haven’t personally seen a…   Read more»

Design control is definitely one of the most important parts of developing a medical device because it helps ensure safety, effectiveness, and regulatory compliance. But when it’s not applied properly, a lot of issues can come up. From what I’ve…   Read more»

To coordinate between risk and verification validation results, a dynamic risk assessment system can be used to consider the results. Verification and validation can uncover problems with a device relating to its design controls, and being able to update a…   Read more»

Yes, I, along with a lot of others I am hoping, do feel safer knowing medical devices go through the verification and validation process not just now, but for the future as well. Off the top of my head, I…   Read more»

From my experience as a QC/QA intern at Case Medical, I’ve seen how validation and verification are similar but serve different purposes. Verification is more about checking that a product was made correctly according to the design. For example, I…   Read more»

FDA and ISO should begin to change their requirements. All of their requirements were written where the submissions were done in concrete steps. Many AI models have algorithms that can change after their initial training and these changes are most…   Read more»

To me, balancing the user needs alongside business goals seems like a hard challenge to accomplish, although also an important part of the development process. From any viewpoint, the ideal position is that the device proposed not only is specified…   Read more»

While I don’t currently work in the medical device industry, the understanding and learning of the difference between verification and validation are essential and closely related cogs in the design control process. Verification is the involvement of checking that the…   Read more»

Yes, I do feel safer knowing that validation and verification are applied to medical devices we use today and may rely on in the future. These processes make sure not only that a device is built correctly, but also that…   Read more»

The best way to translate a qualitative user need into a quantitative design input is to break the need down into measurable characteristics using engineering standards, research, and benchmarking. For example, if a user states the device must be easy…   Read more»

I am in agreement with what everyone has said so far, especially regarding the points about how collaboration and regulatory boundaries are imperative. I also like the emphasis on how pre-planning can help avoid most conflicts before projects even begin….   Read more»

Validation and verification are both crucial parts of the medical device development process, but they serve different purposes. Verification ensures the product meets the specifications outlined in the design- essentially asking, “Did we build the device right?” This involves testing…   Read more»

Engineers should “fight” for an ideal design in a way which describes their design as a benefit to the business. In design, usually user needs will complement business goals. For example, designing a medical device which takes into account rather…   Read more»

I think that defining “success” in quantifiable terms is the first step to converting a qualitative user need into a quantitative design input. If a user requests that a device should be easy to clean you could decide that all…   Read more»

Improper implementation of design control might lead to several issues later on. Problems with the device may not become apparent until the end of development or even after it has been put on the market. It’s quite difficult to determine…   Read more»

Although I haven’t personally witnessed businesses doing this, as I believe a majority of people haven’t, I am aware that certain employees may be tempted to cut corners in order to save time by ignoring unsuccessful verification processes. Doing something…   Read more»

I agree that verification and validation have distinct purposes that keep the design controls objective and therefore reliable. Verification makes sure the device gets the technical specifications down, and validation makes sure that those specifications are actually solving the user’s…   Read more»

In general, there is a clear line between neglect and making mistakes. At times, people might change or alter a process and forget to note it down. Although this is also not the correct way of doing things, especially when…   Read more»

At times, things like regulations may seem like barriers. But in reality, they aid in making a more robust device and reduce the chances of adverse effects (lower risk). At times, some regulations may seem too much and may cause…   Read more»

Since they are two distinct aspects of the product development process, it is important that both are still completed. Although they do overlap, sometimes more significantly than in other cases, it is important to perform both because they both still…   Read more»