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Basics of Unique Device Identification (UDI)

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…

eIFU Requirements Under the EU MDR and Regulation 2021/2226

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, according…

Cybersecurity of Medical Devices in USA

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…

eIFU for Medical Devices: Country Specific Regulations and Benefits

There are several benefits of using electronic Instructions for Use (eIFU) labeling for medical devices, including: 1. Accessibility: eIFUs can be accessed from anywhere with an internet connec…

Technical Documentation – Future proof and save time/costs

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 (…