Controlled change really is what keeps product development from turning into chaos. Some common examples of device changes that need to be controlled include modifications to the materials used, updates to software or firmware, and adjustments to component dimensions or tolerances. Even what seems like a small change, like switching to a new supplier or altering the sterilization process, can have a big impact on performance or safety. Design control ensures each of those changes is properly reviewed, tested, and documented before implementation. That way, if something goes wrong later, there’s a clear trail showing what was changed and why. It’s basically how teams keep innovation moving forward without losing sight of consistency and safety which are major factors when it comes to regulating medical devices that have gone commercial.