The risk in having too many risks…
Confusing failure modes for risks is one of the most common structural mistakes in medical device risk analysis — and one of the most costly to fix later. This article explains the difference between hazards, hazardous situations, and harm under ISO 14971, why a bloated risk analysis undermines your whole risk management process, and how one simple syntax rule can help you build a cleaner, more actionable document from the start.
Crans-Montana, a compliance perspective
In the wake of the devastating NYE fire in Crans-Montana, this post reflects on the critical role of compliance and individual accountability in preventing national tragedies, reminding us that regulation is only a burden until the moment it becomes our last line of defense.
