Blog Home TAG: 21 CFR Part 820

6 Common Reasons External Quality Audits Fail

In FDA and ISO environments, quality audits are a process of examination and substantiation that procedures, records, and activities are effectively aligned with desired objectives. The FDA and [...]


FDA Expands Medical Device Cybersecurity Draft Guidance to Stress Importance of Quality System

As innovation in medical technology increases, potential cybersecurity threats also grow. The U.S. Food and Drug Administration (FDA) expects medical device manufacturers to fully incorporate [...]

Turnkey Quality + Compliance Management
IN ONE VERSATILE SYSTEMManage all quality and compliance activities, control risk and streamline workflow with a single easy platform.

Quality & Compliance Management Software
AssurX Quality + ComplianceA single versatile software system can improve quality, compliance and streamline workflows.