Our Expertise

Risk management

Our experienced team of consultants is skilled at identifying and reducing risk in all types of devices and processes.

Business process services

Leverage our expertise while maintaining a lean, agile business. We can manage all your regulatory and quality operations.

Human factors research & design

Put a safer, more effective, more competitive device in the hands of patients and healthcare providers. Our human factors experts have deep expertise in medical device design.

Related

The latest industry insights from our global team.

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