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Does Your Mobile App Need FDA Clearance?
Are you ready to launch your mobile medical app in the United States? Depending on the functionality of your app, you might need clearance from the
Balancing Aesthetics and Usability in Medical User Interface Design: 9 Key Trends
As the influence of technology in our everyday lives continues to grow, the standard for aesthetically pleasing and contemporary user interface (UI) designs in the healthcare space continues to
Conformity Assessment Routes under the EU Medical Devices Regulation (MDR 2017/745)
European medical device compliance under the Medical Devices Regulation (MDR) will mean new conformity assessment route options. For medical devices
US Regulators Propose Labeling Submission Rules for Higher-Risk Home Use Medical Devices
EMERGO SUMMARY OF KEY POINTS: The US FDA has proposed requiring electronic submission of labeling data for Class II and III home-use devices. Submitted data would be made publically available to