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 News and Resources

The latest industry insights from our global team.

Webinars
Marketing medical devices in the post-Brexit era: Working with a UK Responsible Person (UKRP)
Webinars
Threshold Analyses: Inspecting for User Interface Differences
Webinars
Conducting User Research in Difficult Circumstances
Webinars
The Role of Hardware User Interface Design in Medical Devices