Abstract

Navigating the ever-evolving medical technology (medtech) environment is challenging for medical device manufacturers. For start-ups, meeting market requirements is exciting and intriguing. Quality certification—such as ISO 13485 (medical devices) or medical device single audit program—helps start-ups eliminate potential customer or investor doubts quickly. Quality plays a crucial role in achieving best results and is possible only when everyone in the organization is involved, starting with those at the top. Remembering the acronym QUALITY will help start-ups thrive in the regulated, competitive medtech environment.