
The 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.
The 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.
Effective implementation of UV-C disinfection is crucial to reducing HAIs. The Providence Holy Cross Medical Center achieved a 19% reduction in multidrug-resistant HAIs and saved $1.2 million through strategic deployment, highlighting the importance of collaboration and innovative management.