The new cleanroom at our global headquarters in Salt Lake City, Utah, was designed for today's rigorous contamination control expectations, driven by EU GMP Annex 1. Learn More
Human factors engineering (HFE), also referred to as usability engineering, is a structured, risk-based process intended to reduce use errors and ensure medical devices are safe and effective for their intended users, uses, and environments. As regulatory expectations continue to...
Discussions about reusable medical devices often focus on professional caregivers, but it’s essential to include users responsible for processing these devices. This includes sterile processing personnel in healthcare facilities and lay users processing home-use devices. Instructions for Use (IFUs) for...
