Organising European technical documentation to avoid duplication.
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.
Donawa
Maria
M
Donawa Consulting, Rome, Italy. medonawa@donawa.com
D004282:Documentation / Q000592:standards*; D017598:Efficiency, Organizational; D004864:Equipment and Supplies / Q000592:standards* / Q000600:supply & distribution; D005060:Europe; D005062:European Union; D005568:Forms and Records Control / Q000592:standards*; D019983:Guideline Adherence / Q000458:organization & administration*; D006801:Humans; D008422:Materials Testing / Q000592:standards; D011356:Product Labeling / Q000592:standards; D011358:Product Surveillance, Postmarketing; D011786:Quality Control; D014481:United States; D014486:United States Food and Drug Administration