Regulatory Affairs and Quality System Consulting Services
Our expertise
Looking to navigate the complex regulatory landscape for your medical device? We specialize in CE marking, US IDE and European clinical trial submissions. With our proven track record in transforming regulatory challenges into opportunities, we will help your company prepare compliant submissions to satisfy regulatory requirements.
Our services
CE Marking
Clinical Trial Applications
Quality Management System
Risk Management
Why Choose Our Firm
Excellent Track Record
Achieved CE Marking under EU MDR and clinical trial approvals in the US, Canada, and EU.
Transparent Fees
Billing on an hourly or per project basis, depending on your needs.
Customer Service
We work with all stakeholders to ensure customer satisfaction