Medical Device and Diagnostic Industry (MD+DI)

FDA Clarifies When Software & Wellness Products Are Not Medical Devices

FDA revised guidance documents for low-risk wellness products and clinical decision software, clarifying regulatory ...
MD&M East

Validating Software as a Medical Device (SaMD)

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 ...
The Indianapolis Star

Language Scientific Explains IFU Translation Requirements for Medical Device Documentation

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, ...
JD Supra

FDA Finalizes Its Premarket Submissions Guidance for Medical Device Software Functions

On June 14, 2023, FDA finalized its “Content of Premarket Submissions for Device Software Functions: Guidance for Industry and Food and Drug Administration Staff” (the “2023 Final Guidance”). The ...
Des Moines Register

Language Scientific Breaks Down Common Risks in Translations for Medical Device Companies

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 ...
RAPS

IMDRF drafts framework on best practices for using AI in medical devices

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 ...