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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 · Combination Products

EPR, EDO, EDDO, EP, PF: Sorting the Alphabet Soup

Five terms, four sources, and no document anywhere that maps them to one another. Two of them are almost the same word and mean different things. Where each sits on the design control chain, and what the classification actually obligates you to verify.

5 Oct 202611 min read

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Quality Systems

CAPA Effectiveness Checks That Actually Close the Loop

"Retrained the operator. Training records on file. CAPA closed." Nothing in that record is false — it just never establishes whether the problem stopped. What separates a completion check from a real effectiveness check.

5 Sep 202610 min read

Statistics

Process Capability (Cpk and Ppk): What Auditors Actually Expect

A capability index compresses an entire process into a single verdict. What the indices actually measure, the three prerequisites nobody documents, and why an observed Cpk of 1.33 is weaker evidence than it looks.

7 Aug 202610 min read

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. What genuinely changes, what stays, the FDA-specific requirements that remain, and a practical transition sequence.

15 Jun 20269 min read

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

Combination Products

21 CFR Part 4: One Quality System for a Combination Product

The streamlined approach lets you run a single quality system instead of two. What it actually requires, how to choose your base system, and the integration gaps that surface in audits.

28 Apr 20269 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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