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
The Role of Hardware User Interface Design in Medical Devices
Regulatory Updates
Tips for a successful FDA Human Factors meeting, Part Two: Meeting attendance and follow-up
Webinars
Human factors consideration as it applies to Software as Medical Device (SaMD)
Regulatory Updates
CRADA report from UL and US VA: Procurement as driver of medical device cybersecurity