AssurX Blog
Straight talk for regulated industries.
FDA Updates Cybersecurity Guidance for Medical Devices: 2025 Premarket Recommendations
The U.S. Food and Drug Administration (FDA) released an updated guidance document in June 2025, titled “Cybersecurity in Medical Devices: Quality System Considerations and Content of [...]
5 Essential Elements Shared by Leading Supplier Quality Management Systems
Global-scale events have tested the bounds of a supply chain system. The coronavirus, for example, has made it clear how critical an efficient supply chain is for continuity and surviv [...]
Why Quality Audits Are Critical for Compliance in FDA and ISO Environments
Quality audits are a cornerstone of compliance in FDA and ISO-regulated environments, ensuring that procedures, records, and activities align with stringent regulatory standards. Thes [...]
QMS Validation: How CSA Reduces Documentation Without Increasing Risk
Documentation has long been at the heart of quality management system (QMS) validation, particularly in regulated industries such as pharmaceuticals and medical devices. In environmen [...]
Supplier Scorecards vs. Spreadsheets: Risks of Manual Tracking
Spreadsheets are usually the first tool used to manage suppliers, and the first to become a liability. Important updates get buried. Repeat supplier problems start popping up. Along th [...]
QMS Software: When to Configure and When to Customize
When it comes to managing quality and compliance in today’s regulated industries, selecting the right enterprise QMS software is a strategic decision. Many vendors claim their QMS soft [...]
