Articles on FDA's CSV-to-CSA transition, IEC 62304 risk classification, AI-assisted code validation, and the practical mechanics of a Design History File. Written for Quality Engineers, by people who've sat in the audit chair.
The productivity inversion I live in every day. AI builds in minutes. Validation still takes the same hour it did in 2002. Both sides are honest about why.
CSA is what the FDA wants you to do. CSV is what your QMS still says to do. The gap between those two sentences is where most quality teams are stuck.
Concrete examples per class. The misclassification trap. What auditors actually look for.
The PCCP framework, the bias-and-representativeness problem, the time-bound submission opportunity.
The seven things auditors check, what counts as evidence, why SHA-256 hashes matter.
A four-part structure, before-and-after example, what to cut and what to add.
The three failure modes that look different from human-written code. What to test for. Where teams cut corners.