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.

Regulatory Updates
Canadian regulators issue new reporting requirements for medical device shortages

Sun Dec 05
Regulatory Updates
The modern era of potential use error

Wed Nov 10
Regulatory Updates
Crafting effective use scenario prompts: A key to medical device usability test success

Wed Sep 15
Regulatory Updates
Singapore HSA recommends cybersecurity protections against BrakTooth for Bluetooth medical devices

Tue Sep 07