Showing posts tagged with: procedures

So, you are a medical device creator and you reached to the point when you see that SOP (Standard Operating Procedure) is required by the FDA, ISO, and other regulatory bodies. But what SOP actually means? By definition, it’s a document that describes the regularly recurring operations relevant to the quality of the investigation. The aim...

Every company has as part of its organization set of procedures and processes. The purpose of having procedures is to drive efficiencies towards fewer errors and resulting reworks, which can improve cost saving. Besides that, their purpose is also to make sure they are in compliance with regulations. The procedure is correct, but are the follow-ups? But...