Author: Anne Holland, CEO and Founder Navigating the New Quality Management System Regulation: Insights from Our Latest White Paper We…
Author: Ella Wheeler, Director of Operations and Senior Quality Engineering Consultant Continuous Improvement (CI) is no longer a slow and…
Author: Emerance Gummels, Principal Software and Regulatory Consultant Cybersecurity for medical devices is crucial to protect patient data and device…
Author: Ella Wheeler, Director of Operations and Senior Quality Engineering Consultant As medical device manufacturers strive to bring innovative products…
Author: Sallie McLaughlin, Principal Microbiology Consultant Understanding and Overcoming Sterility Test Failures in Medical Device Radiation Dose Audits Paying close…
Author: Anne Holland, CEO and Founder As we move into 2022, we decided to take a step back and look…
Author: Amber Hilfiger, Director of Operations and Principal Quality Engineering Consultant No one wants an FDA investigator to find an…
Author: Silas Minnick, Senior Quality Engineering Consultant On September 29, 2021, the FDA issued a draft guidance regarding a new…