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.
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.