Our Expertise

Regulatory strategy

Leverage approvals in key markets to expand globally. We’ll design a regulatory and quality strategy that takes your product to established and emerging markets worldwide.

RA/QA business process services

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

Post-market compliance

Regulatory compliance doesn’t end when your device goes to market. We design compliance solutions informed by a life-cycle approach to device safety and effectiveness.

Related

The latest industry insights from our global team.

Wearables vs. Regulated Medical Devices under the US FDA
One of th e biggest challenges for companies in the general wellness space is understanding how and when their technology might encounter FDA
Applying human factors to wearable medical devices
White paper: Applying human factors to wearable medical devices
The wearable medical device landscape is changing rapidly. An increasing number of medical devices that have traditionally stayed in place are
Apple Issues More Explicit Guidelines for Mobile Medical and Health App Developers
Apple has published updated guidelines for how the company reviews applications submitted for sale via its App Store, with an expanded section focused on safety requirements for health and medical
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