Guest
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?
Assign topic to the user
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more 
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
Expert
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.
Comment as guest or Sign in
Apr 27, 2022
Apr 29, 2022
Apr 29, 2022