Tag Archives: Medical Device Compliance

Complaint Handling Under QMSR: Where the FDA Audit Trail Begins

Short answer: Since February 2, 2026, complaint handling under 21 CFR Part 820 is governed by ISO 13485:2016 Clause 8.2.2 together with FDA's supplemental record requirements in § 820.35. Medical Device Reporting under 21 CFR Part 803 did not change: manufacturers must report a death, serious injury, or reportable malfunction within 30 calendar days of

Is Your Product Still an FDA-Regulated Device in 2026?

The Answer Might Surprise You. One of the most common questions we have received from manufacturers, software developers, and startup founders this year is: Is my product still considered a medical device by the FDA?" The short answer is: maybe not—but don't assume. In 2026, the FDA continued refining its approach to certain low-risk health

What FDA Inspectors Are Actually Checking Under the New QMSR — MDI’s First-Hand Findings

What FDA Inspectors Are Actually Checking Under the New QMSR — MDI’s First-Hand Findings The single biggest focus area in every QMSR inspection that MDI has participated in is not your quality manual, SOPs/work instruction, documentation structure or your terminology — it is your organizations ability to demonstrate risk-based thinking embedded throughout your entire quality