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PubMed · 16736662

Organising European technical documentation to avoid duplication.

Maria Donawa
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Abstract

The development of comprehensive accurate and well-organised technical documentation that demonstrates compliance with regulatory requirements is a resource-intensive, but critically important activity for medical device manufacturers. This article discusses guidance documents and method of organising technical documentation that may help avoid costly and time-consuming duplication.

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DocumentationEfficiency, OrganizationalEquipment and SuppliesEuropeEuropean UnionForms and Records ControlGuideline AdherenceHumansMaterials TestingProduct LabelingProduct Surveillance, PostmarketingQuality ControlUnited StatesUnited States Food and Drug AdministrationJournal Article

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Maria Donawa. 2006. Organising European technical documentation to avoid duplication.. https://pubmed.ncbi.nlm.nih.gov/16736662/

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