History has shown that regulatory missteps can derail even the most promising medical devices. One example is the Dalkon Shield, an intrauterine device (IUD) that was introduced in the 1970s without s...

One of the biggest challenges in medical device project management is balancing regulatory compliance with innovation. The FDA’s mission is to ensure safety and efficacy, but sometimes, these requirem...

A strong regulatory strategy is important for project management in the medical device industry. Without it, companies risk costly delays, failed approvals, and even market withdrawal. One key aspect ...

Risk management is a fundamental part of project management, especially in highly regulated industries like medical devices. Every project carries risks—technical failures, budget overruns, regulatory...

One of the biggest challenges in project management is balancing the triple constraint—time, cost, and scope. In medical device development, each of these factors is crucial. For example, if a company...

Project management (PM) is the backbone of innovation in the medical device industry, ensuring that ideas become tangible solutions that improve patient care. At its core, a project is a structured ef...