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, ...
FDA revised guidance documents for low-risk wellness products and clinical decision software, clarifying regulatory ...
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 ...
The safety and security of medical devices driven by software, the software-development processes, and the need for data collection and privacy, all offer challenges and opportunities for device ...
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 ...
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