Environmental Health Care Corner with Alexandra Peters, PhD
January 30th 2025
Despite revolutionary advancements like alcohol-based hand rubs, infection prevention still faces major hurdles. Poor adherence to hygiene, overreliance on technology, and understaffed environmental services create perfect storm conditions for deadly outbreaks.
Implementing FDA 21 CFR Part 820 & ISO 13485 on Quality System Regulation
August 30th 2024The FDA's 21 CFR Part 820 and ISO 13485 are crucial in regulating medical device quality systems. Harmonizing these standards by 2026 will streamline compliance, improve patient access to devices, and align US regulations with global practices.