Tag: Understand

Understand and avoid deviations and non-compliance

Deviations, non-conformities, errors, findings and other terms are often mistakenly used synonymously. The standards also explicitly contradict each other when defining individual terms. This article clarifies how the terms should be understood, what are the causes and consequences of non-conformities e how medical device manufacturers can avoid these deviations and non-compliances. 1. Non-compliance: basics 1.1…