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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 · Risk Management

Use-Related Risk Analysis: Where Probability Stops Working

ISO 14971 defines risk as probability times severity. Then you reach use error, and FDA tells you probability is very difficult to determine and severity is the more meaningful quantity. What that means for your URRA, your critical tasks, and what fifteen validation participants can actually demonstrate.

5 Nov 202611 min read

In this article

  • Why probability fails for use error
  • Critical tasks, including compromised care
  • What fifteen participants can and cannot tell you
  • Why labeling and training sit at the bottom
Combination Products

EDDO Is Now EDDC: Sorting the Combination Product Alphabet Soup

In under three years FDA has given the same concept three names — EPR, then EDDO, now EDDC in the October 2026 revised draft. Where each term sits on the design control chain, and what the classification obligates you to verify.

5 Oct 2026Updated 31 Oct12 min read
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

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

New articles are published periodically. Have a topic you would like covered, or a question about your own program? Get in touch.

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