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
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

Webinars
Impact of the FDA Premarket Guidance of Management of Cybersecurity in Medical Devices