Some of the consequences that may arise from the from faulty design controls is that the product can be more likely to fail and there is no fail safe options when it come to the fixing the broke product or…   Read more»

The best way to translate a qualitative user need into a quantitative and testable design input is to follow an iterative process of user analysis, measurable criteria definition, and engineering translation. First, the design team should clarify the intent behind…   Read more»

When it comes to the design controls be in place, I find that it will in fact lead to better results and help with innovation of the products as it places rules in place to limit the amount of risk…   Read more»

In practice, successful design teams balance user needs and business realities through structured trade-offs rather than choosing one side completely. Engineers should advocate strongly for essential user requirements—those that affect safety, performance, or regulatory compliance—because compromising these can cause product…   Read more»

Having both design verification and validation as separate processes is necessary because they address fundamentally different questions in product development. Verification ensures that the design outputs meet the design inputs — it’s about technical accuracy, consistency, and compliance with specifications…   Read more»

When it comes to looking at companies who that neglect necessary steps to for the design process and other QA and QC process, I don’t know of many that do cut the corners to get their products to get them…   Read more»

While design controls under regulations like ISO 13485 and FDA 21 CFR 820 can feel restrictive, they actually play a dual role in innovation. On one hand, they slow things down by adding documentation, formal reviews, and verification steps that…   Read more»