Successful risk management is essential to the design and development of safe and effective medical devices. Unfortunately, it is too often viewed by manufacturers as an isolated activity that must be ...

When it comes to process-control systems, reliability is crucial and failure can be costly or dangerous. A combination of good design practices, component selection, and testing can enhance ...

In January 1990, FDA published Device Recalls: A Study of Quality Problems (55 FR 21108, May 22, 1990). The study reported that 44% of quality problems were attributed to errors or deficiencies that ...

Why does anything have to change? A manufacturing company’s most critical product decisions are made every day in design reviews. And if you assess the state of what a design review looks like today, ...

AURORA, IL / ACCESSWIRE / May 15, 2024 / Trusted eQMS provider QT9 Software announces the upcoming release of two new modules, Product Design Controls and Quality Events Management, that simplify ...