Verification and validation each have their own distinct purposes. Verification ensures that a design meets specific technical requirements and validation ensures that the design meets the user needs. Although they are different, there are situations where these processes can be…   Read more»

Customer feedback is very important to the design input process because it drives user needs. In some cases, feedback can be ambiguous and cause challenges in translating the designs into reality. Some ways that design teams can handle this are…   Read more»

Design teams prioritize customer feedback by analyzing it against the product’s intended use, market needs, and regulatory requirements. In cases where feedback is ambiguous or conflicting, teams can use techniques like focus groups and surveys to clarify. Critical feedback that…   Read more»

I agree that it is possible to conduct validation and verification simultaneously in some cases, but that should not be the norm or the goal. It’s best to keep verification and validation separate to ensure clarity in evaluating if the…   Read more»

  To define success criteria, a team should start by thoroughly understanding the device’s intended use, regulatory requirements, and user needs. The team must collaborate with stakeholders to outline clear, measurable, and objective performance metrics based on design inputs and…   Read more»

One key aspect often emphasized in risk management for medical devices is the importance of post-market surveillance. Beyond initial compliance with ISO 14971, ongoing monitoring after a device enters the market can identify real-world risks that may not have been…   Read more»

When integrating Poka-yoke as a proactive risk management strategy, one essential consideration is designing error-proofing techniques tailored to the specific tasks and environments in which they’ll be used. For example, in the automotive industry, color-coded components are often used to…   Read more»

In quality control within the manufacturing process, risk avoidance can be implemented through several proactive measures. One specific example is the use of automated inspection systems, like laser-based scanners or machine vision technology, to ensure that every component meets exact…   Read more»

I agree with others. I believe that to define success criteria, a team first engages stakeholders to understand their needs and expectations. They set clear, measurable objectives that align with the project’s overall goals. The team gathers detailed requirements, including…   Read more»

Verification ensures a product meets its design specifications, while validation ensures it meets user needs. These processes can be conducted simultaneously, especially in iterative and agile development methodologies. Integrating both allows for early detection of issues, improving product quality by…   Read more»

I think design teams prioritize customer feedback by identifying common themes across various sources. They segment customers into distinct user personas to tailor solutions to specific needs. Prioritization frameworks like MoSCoW or the Kano Model help assess which features to…   Read more»

I agree, after learning about verification and validation this week, I’ve gained so much knowledge about the safety and reliability of the medical devices we use. It definitely makes me feel much more confident in its safety and reliability.  Verification…   Read more»

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»