Hi elm33, After this week’s lecture, I feel a lot safer knowing about Verification/Validation. These steps are there to catch flaws early on, and if the device will perform its intended function. Verification is there to test if the design…   Read more»

Verification tests whether design outputs match design inputs. Validation tests whether design outputs satisfies user needs. In my previous job as a Quality Engineer, I took part in the verification tests and validation activities. During the verification tests, we had…   Read more»

Hi elm33,Yes after this week’s lecture and learning about validation and verification processes I do feel safer using medical devices. We learned that these steps are in place to ensure that devices meet strict design standards and work effectively in…   Read more»

Hi cem34,It goes without saying that neglecting to record unsuccessful instances during design verification in the name of saving time is a serious ethical violation. This increases risk and reduces the reliability and safety of the final product. Recording all…   Read more»

Hey jbh8,In addition to decreased failure rates and fewer recalls, software validation improves user trust and satisfaction. This is because validated software ensures reliable performance which ends up enhancing the user’s experience. Also, in regulatory compliance, validated software meets industry…   Read more»

In my opinion I do believe that over-validation can happen easily as companies want to make sure their product is proper. I do though feel like teams want to secure the goal with as little work as possible in the…   Read more»

Hello!  In my opinion, meeting minutes do matter as long as all topics and information was laid out on the table. Sometimes I find that when a meeting minutes time is established, people tend to worry on how long the…   Read more»

One way to improve design transfer is to implement the use of CAD drawings so manufacturing can better understand how to make the product. This can include a Bill of Materials, and what to include and not include in the…   Read more»

Literature research can be a big help in designing success criteria for a study. Looking at similar successfully released products can provide a great roadmap on defining what success means. This is important to do well the first time, because…   Read more»

The Design Transfer Document is the answer to the first question. As long as all inputs/outputs are exhaustively documented, production errors should be kept to a minimum. Keeping a member or two of production in the loop during creation of…   Read more»

Design minutes, while often ignored, I think are a very valuable tool. For one, they help to ensure accountability. If minutes are kept, they can always be referred back to if someone was given a responsibility or a decision was…   Read more»

I would think of it as a multifunctional device. Usually, you would not expect a vacuum robot that is small and can also mop the floor to be as good in vaccuming the floor like a simple vacuum cleaner. Same,…   Read more»

To me, insufficient design control basically means that you are not foreseeing enough problems that can incur during the development of the product. That basically means that you do not have enough “test case” to plan to test your product…   Read more»

To my experience, meeting minutes are ver very important. They are brief but has important information in them. We can track how the project progress through the minute and is a great resource to keep track or look up something….   Read more»

Coordinating risk evaluations with design verification and validation results to assess potential risks throughout the development process is incredibly important. Failure Modes and Effects Analysis (FMEAs) and Hazard Analysis are two commonly used techniques that help with assessing these risks….   Read more»

Great question Samiha! In my opinion, when transferring design control and standards to any contract manufacturer, especially in medical device production, companies must consider several critical issues or limitations to ensure compliance and quality. First, quality control consistency is critical….   Read more»

Both design validation and verification serve as the vital steps in the medical device development since they maintain both product quality and regulatory compliance. Regulations such as, FDA QSR and ISO 13485 involve them, and they need detailed records showing…   Read more»