
Medical Devices and IVDs

Bring innovative medical device, IVD and combination products to market with our consulting and training services.
Establish, audit or remediate your quality systems with guidance from our team of former regulators. Our experts help you prepare for market, mitigate risk and achieve sustainable compliance with country-specific regulations and international standards.
How Can We Help?
Support During COVID-19
Our team is here to help you and the health care industry through these uncertain and fast-moving times.
Learn more about our services and support
Emergency Use Authorization Services
Our team can help you determine the appropriate pathway for your device and navigate the EUA process.
EUA Support Services for the Medical Device Industry