To protect both the user and patient, medical device developers must pay strict attention to the safety of a device's software. Risk-mitigated software design is crucial. Timothy Cuff and Steven ...

Many medical device companies develop software using a traditional waterfall methodology in which each step is taken in sequence: requirements, design, implementation, verification, and validation ...

A monthly overview of things you need to know as an architect or aspiring architect. Unlock the full InfoQ experience by logging in! Stay updated with your favorite authors and topics, engage with ...

This morning the FDA released two guidance documents relating to the regulation of various digital health software devices. The first is a draft guidance outlining categories of clinical decision ...

Kimberlee Leonard has 22 years of experience as a freelance writer. Her work has been featured on US News and World Report, Business.com and Fit Small Business. She brings practical experience as a ...