Yes—absolutely.In fact, regulatory strategy is most powerful before a physical prototype exists. At the earliest stage, regulatory thinking acts as a design compass. It tells you […]
When regulatory strategy starts after prototyping, things don’t just slow down—they break. And once they break, they are expensive to fix. Medical device development is not […]
Direct answer: regulatory strategy should start at the idea stage, not after you build a prototype. If you wait until the device is engineered to think […]
How rushing to close issues creates shallow solutions—and repeat failures Speed is often praised in regulated environments. Fast responses look decisive. Quick closures look efficient. Leaders […]