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 News and Resources

The latest industry insights from our global team.

Regulatory Updates
Enabling safe and effective diagnostic tests, treatments and monitoring at home
Regulatory Updates
Self-selection Studies: Guarding against contraindicated use of OTC medical products
Regulatory Updates
US FDA updates guidance for telehealth and digital products qualifying as medical devices
Regulatory Updates
Human factors studies: Considerations for recruiting rare and complex user populations