TrendWatch
The post-market signals that matter, read through a quality engineer’s eyes.
A free weekly brief for RA/QA teams. One FDA recall teardown, the public evidence behind it and a practical lesson for your CAPA system. The opening series examines eight closed recalls.
The public evidence
MAUDE reports alongside FDA recall records, with source dates and clear limits on what the data can establish.
Closed Class I recalls
Historical failures and corrections examined in detail. These are lessons from the public record, not current recall alerts.
The Teardown
One failure each week, traced to a probable root cause, with the CAPA/PMS lesson for your own quality system.
Every Tuesday, around 7am ET. Facts linked to their sources, analysis labelled and one practical lesson. Written by a quality systems engineer who builds post-market surveillance tools.