Eliza Johnson, BS, CRCST, has a strong passion for helping others throughout the health care and medical device industries. She currently works as a quality specialist at ARCH Medical Solutions, where she delves into medical device manufacturing processes, utilizes quality and compliance systems, and completes essential quality system documentation. This role builds upon her 2 years as a CRCST at Exeter Hospital, where she gained experience decontaminating and sterilizing medical devices in preparation for surgical use.
Artificial intelligence may be revolutionizing sepsis detection and diagnosis, but can we trust it without strong regulatory guardrails? As AI/ML-enabled medical devices rapidly evolve, IPs must stay informed and involved to ensure safety keeps pace with innovation. Let’s take a closer look at how to advocate for innovative safe implementation.
Creutzfeldt-Jakob Disease (CJD) presents significant challenges for infection control. Learn best practices for safe instrument disposal, reprocessing, and compliance with CDC and WHO guidelines.
Learn more about how effective air pressure regulation in health care facilities is crucial for controlling airborne pathogens like tuberculosis and COVID-19, ensuring a safer environment for all patients and staff.
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.
Utilizing robust quality systems is essential in medical device manufacturing to prevent infections and extend the lifespan of instruments, ensuring optimal patient safety.
Published: July 24th 2024 | Updated:
Published: August 30th 2024 | Updated:
