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Rodent and Pest Control Program for Medical Device Manufacturing

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Shannon Maxwell Created:   Apr 27, 2022 Last commented:   Apr 29, 2022

Rodent and Pest Control Program for Medical Device Manufacturing

Does ISO 13485 or some other FDA regulation require Rodent/Pest Control programs for Medical Device manufacturers similar to those required for GFSI Food Safety food contact manufacturers?

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Kristina Zvonar Brkić Apr 29, 2022

There are no direct requirements regarding pest control in ISO 13485:2016. However, in requirement 6.4 Work environment is stated that the manufacturer must document the requirements for the work environment if the conditions for the work environment can have an adverse effect on product quality. Therefore, if the appearance of pests can affect the quality of the product, then it is definitely necessary to conduct pest control.  

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Apr 27, 2022

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