Author: Anne Holland, CEO and Founder
The countdown is on for the Quality Management System Regulation (QMSR) transition. While at first glance the changes from 21 CFR Part 820 to the QMSR may seem minimal, the truth is that “the devil is in the details.” Small adjustments in wording, cross-references, and structure can have a major impact on compliance, operational efficiency, and audit readiness.
If you haven’t yet taken a close look at your quality system, now is the time. The first step is conducting a gap assessment to identify where your current procedures align—or fall short—of the new requirements. This is especially important for organizations that have been working with longstanding SOPs or documentation that may have subtle differences from the ISO 13485-aligned QMSR expectations.
Updating your Quality Manual should be at the top of your list. This document is the cornerstone of your QMS, and aligning it with QMSR language, references, and intent will create a strong foundation for the rest of your documentation updates. Don’t underestimate how even small language changes—such as terminology adjustments or updated clause references—can trip up your compliance if they’re overlooked.
The clock is ticking. Every day without a completed gap assessment is a day closer to potential nonconformance. If you haven’t yet assessed your readiness, we can help. Our team will guide you through a thorough gap analysis, ensuring your quality system is robust, compliant, and ready for the shift. Talk to one of our experts today.
Lean into quality with medical device systems everyone can trust—starting now, not later.
