Author: Ella Wheeler, Director of Operations and Senior Quality Engineering Consultant Continuous Improvement (CI) is no longer a slow and…
Read More
Author: Ella Wheeler, Director of Operations and Senior Quality Engineering Consultant As medical device manufacturers strive to bring innovative products…
FDA Inspection Observations (483s) — Current Trends and Preventing Escalation Ideally, you will have tactics and strategies in place to...
Read More
Ready, Set, Prep for the Four Types of FDA Inspections As a medical device manufacturer, Federal Drug Administration (FDA) inspections...
Read More
ISO 13485 Requirements and Audits: “What’s the Best Way of Doing This?” Align with the Latest Version of ISO 13485...
Read More
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Author: Silas Minnick, Senior Quality Engineering Consultant On September 29, 2021, the FDA issued a draft guidance regarding a new…
