Design verification checks if we built the product right, while validation checks if we built the right product for the user. Both are required, but they often overlap in testing and documentation. Is it really necessary to have both processes…   Read more»

The lecture made it clear that design starts with user needs, what the device should do, for whom, and in what environment. But in real companies, business goals like cost, timeline, and market size are also huge factors. How should…   Read more»

After learning about how strict design controls can be — from defining user needs to managing risk and verifying every output — I started wondering if they sometimes slow down innovation. Regulations like ISO 13485 and FDA 21 CFR 820…   Read more»