Our Expertise

Risk Management

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

Digital Health

Our experts help identify cyber risks that may be introduced through your suppliers or to your technology infrastructure via procurement.

Human factors research & design

Our human factors experts know how to reduce the friction between healthcare providers and the devices they use every day through better, safer design.

Related

The latest industry insights from our global team.

Final US FDA Guidance on Post-market Cybersecurity Risk Management
EMERGO SUMMARY OF KEY POINTS: The US FDA has issued final guidance regarding post-market cybersecurity risk management for medical devices. The final guidance comes about a year after the FDA
Health Canada Crafting Rules for Mandatory Incident Reporting by some Hospitals
New mandatory medical device incident reporting rules proposed by Health Canada Scope includes all acute-care hospitals in Canada 30-day timeframe for incident reporting proposed
Human Factors Engineering and Usability: What you should know about diary studies
EMERGO BY UL SUMMARY OF KEY POINTS: Use of diary studies as tools for human factors research and design applications increasing Diary studies providing more efficient access to longitudinal data
US FDA Issues Design, Submission Recommendations for Interoperable Devices
Medical device regulators at the US Food and Drug Administration have published new guidance targeting how manufacturers of electronic interoperable devices design their products as well as what to