Global Medical Device Registration
Professional global medical device registration services covering market entry management for all product categories.
In-country Authorized Representative
Acting as an independent local authorized representative to ensure seamless control of medical device registrations.
RA/QA Consulting & Training
Professional regulatory affairs and quality assurance consulting and training services to tackle complex regulatory challenges.
Post-Market Surveillance
Providing post-market regulatory compliance solutions to ensure medical device safety throughout their entire lifecycle.


Global Medical Device Registration
Our registration services cover the complete lifecycle of medical device approvals, ensuring your products meet all regulatory requirements for global market entry.
Complete registration management for all product classes
End-to-end support from compilation to submission
Comprehensive regulatory compliance
Global market entry strategies


In-country Authorized Representative
We serve as your trusted local representative, providing deep regulatory knowledge and ensuring your medical devices maintain compliance throughout their market presence.
Independent local representation for device companies
Seamless control over device registrations
Local regulatory expertise
Ongoing compliance monitoring


RA/QA Consulting & Training
Our consulting services provide strategic guidance and hands-on support to navigate complex regulatory landscapes and build internal capabilities.
Integrated regulatory strategies and solutions
Outsourced personnel and comprehensive support
Custom training programs
Quality assurance consulting


Post-Market Surveillance
Our surveillance services ensure ongoing compliance and safety monitoring throughout your medical device's market lifecycle, from launch to retirement.
Comprehensive post-market compliance solutions
Life-cycle approach to device safety and efficacy
Incident reporting and management
Continuous monitoring and support