Necessary facility requirements to build medical devices

This really depends on the type of medical device that you produce. Facility requirements are not the same for example, for the software or sterile gauze products. 

If you have a sterile medical device then it is necessary to monitor the cleanliness of the production premises. Usually, medical devices that need to be sterilized are produced in a cleanroom. Requirements necessary for the cleanroom are stated in the ISO 14644 family of standards. 

Depending on the type of sterilization, each method has its own facility requirements.

Storage place is also important if there is a strict requirement for the storage temperature and humidity. 

For more information, please see the following article:

• Managing medical device infrastructure requirements according to ISO 13485:2016 https://advisera.com/13485academy/blog/2017/06/28/managing-medical-device-infrastructure-requirements-according-to-iso-13485/