Tag: avoid
Way to avoid a PMA?
THE De novo procedurethe FDA also speaks of the “de novo program” and the “de novo submission process”, which is one of the approval procedures for medical devices in the USA. Manufacturers can use this process – as the name “de novo” suggests – for new types of products. This means that manufacturers would have…
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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…
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