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Practical guidance on quality, risk & data

Working notes from the field — what the standards actually require, where programs get stuck, and how to build evidence that holds up under audit. Written for quality, regulatory, and R&D teams in medtech and combination products.

QMSR & ISO 13485 ISO 14971 Statistics 21 CFR Part 4 Design Controls
Latest · Quality Systems

The QMSR Transition: What Actually Changes in Your Quality System

The FDA's Quality Management System Regulation incorporates ISO 13485:2016 into 21 CFR Part 820. Most teams over-estimate the documentation churn and under-estimate the terminology and records work. Here is what genuinely changes, what stays, and a practical transition sequence.

15 Jun 20269 min read

In this article

  • What the QMSR does and does not change
  • FDA-specific requirements that remain
  • Terminology shifts that ripple through your DHF
  • A six-step transition sequence
Statistics

Sample Size Justification for Design Verification

"We used n=30 because we always use 30" is not a justification. A practical framework for choosing and defending sample sizes using confidence/reliability, the success-run theorem, and tolerance intervals.

20 May 202610 min read
Risk Management

What Auditors Look For in an ISO 14971 Risk Management File

Most risk files fail on the same four things: broken traceability, control options applied out of order, a thin overall residual risk conclusion, and no production feedback loop. Here is how each gets found.

17 Mar 20268 min read

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