In today’s fast-paced, highly regulated industries, companies are under constant pressure to meet strict compliance standards. For businesses operating in sectors like pharmaceuticals, medical dev…
In today’s fast-paced regulatory landscape, staying compliant while managing vast amounts of documentation can feel overwhelming. Automated document management is emerging as the game-changer for …
As per the FDA, the term Software as Medical Device (SaMD) is defined as “software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware…
What is an eIFU?
In general, an eIFU is defined as a non-paper version of the instructions for use. Currently, the definition of an eIFU is not the same in each market.
In the EU, accordin…
What is UDI?
An UDI is a distinct numeric or alphanumeric code used to identify medical devices throughout healthcare supply chains. These codes are generated by product owners based on g…
