title: To Be or not to Be a Medical Device: Is the Regulatory Framework a Safety Rope or a Fetter?
authors.affiliation: Prof. Dr. Rainer Röhrig, Carl von Ossietzky University, Department for Medical Informatics, 26111 Oldenburg, Germany, E-mail: Rainer.Roehrig@uni-oldenburg.de.
authors.forename: R
authors.initials: R
authors.lastname: Röhrig
mesh_terms: D004864:Equipment and Supplies / Q000592:standards*; D033161:Government Regulation; D012984:Software / Q000331:legislation & jurisprudence*; D014481:United States
keywords: Software as a medical device; medical devices/legislation and jurisprudence; medical devices/standards; regulatory affairs; stand alone software