Medical Device Regulatory & Engineering Blog

When you start developing a medical device, you have a reason, a problem that you want to solve. One of the first things you need ...

Laboratory Developed Tests (LDTs) play a pivotal role offering customized diagnostic solutions developed and validated within individual laboratories. For medical device manufacturers, understanding LDTs is ...

Minimally invasive devices have revolutionized surgical and diagnostic procedures, offering significant advantages over traditional approaches. These devices are designed to minimize trauma to the body ...

Plan Do Check Act (PDCA) is a versatile and universal concept that has no industry boundaries, making it applicable to virtually any field or business. ...

If you're in the medical device industry, you've probably heard the buzz around EUDAMED. This isn't just another regulatory hurdle; it's a game-changer for how ...

The COVID-19 pandemic has pushed the adoption and use of remote patient monitoring devices significantly. The use of Telemedicine, which includes Remote Patient Monitoring (RPM) ...

Remanufacturing of medical devices means according to 21 CFR Part 820.3(w) "To process, condition, renovate, repackage, restore, or any other act done to a finished ...

Getting your product from idea to market is a journey filled with critical milestones. Two of these crucial stages are Proof of Principle (PoP) and ...

Portable medical devices are compact, mobile healthcare tools designed for personal use or by healthcare professionals. These devices allow for real-time monitoring and management of ...