Using and controlling subcontractors.
The use of subcontractors for the provision of goods and services is an increasing fact of life in the medical device industry. Many specialist subcontractor companies do nothing but fulfil the needs of primary manufacturers. This article examines the quality system and compliance aspects of using subcontractors and makes reference to the recent recommendations from the European Notified Bodies Group on Medical Devices.
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Russell Square Quality Associates Limited, London, UK.
D003284:Contract Services; D004864:Equipment and Supplies / Q000592:standards*; D005060:Europe; D005161:Facility Regulation and Control; D017408:Guidelines as Topic; D006801:Humans; D011786:Quality Control