Medtech developers incorporating AI or machine learning into medical devices need to recognize if and how FDA will regulate ...

Software in the healthcare industry has come a long way over the past 20 years. Medical device companies, like most life sciences companies, were a bit hesitant to incorporate software and automation ...

Language Scientific has provided a practical overview of IFU translation requirements for medical device documentation, emphasizing how clear and accurate Instructions for Use support patient safety, ...

The International Medical Device Regulators Forum (IMDRF) has released a draft technical document to create a harmonized set of best practices in mitigating risks associated with the use of artificial ...

Language Scientific has shared an overview of common risks in translations for medical device companies operating across regulated markets, with a focus on how small language and formatting issues can ...