Applicability of ISO 13485 for medical device store

Answer:

In the context of a medical device store, Good Distribution Practice (country specific regulation) would be more applicable in your case . ISO 13485 is an international standard and guideline to provide medical device companies a framework to establish their Quality Management System (QMS). For the context of a medical device store, your role would be more involved in ensuring that product that does not conform to requirements are identified, segregated, stored appropriately to prevent their unintended use or delivery.