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 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…
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, acco…
Anyone submitting a premarket application or submission for a device classified as a “cyber device” must include information required by the FDA to ensure the device meets cybersecurity requiremen…
Technical Teams often produce a large percentage of their documents and Inefficiencies are introduced when teams create long and complex technical documents like GSPR, STED, regulatory documents (…
