Our Services
Patient concierge, regulatory affairs for medical device companies, and an industry membership platform — three pillars supporting healthcare globalization.
PMDA SubmissionFDA 510(k)CE MarkingISO 13485
3
Core Service Lines
500+
Corporate Clients
15+
Years Experience
24/7
Support
Three Core Service Lines
Patient concierge · B2B regulatory · Industry platform
PATIENT
Medical Concierge
End-to-end support for international patients seeking care in Japan.
- Specialist matching (oncology, cardiology, fertility, regenerative)
- 24/7 multilingual medical interpretation
- Visa, lodging, airport transfer
- Post-treatment follow-up
B2B
Medical Device QA/RA Consulting
PMDA / FDA / CE submission & QMS system building.
- PMDA filing / approval / certification
- FDA 510(k) / De Novo
- CE (MDR / IVDR) compliance
- QMS / ISO 13485 build-up
MEMBERSHIP
Membership Platform
Regulatory intelligence, education, and templates for the medical device industry.
- Monthly PMDA / FDA / CE webinar
- QMS / GVP template library
- Inspection-readiness training
- Weekly member newsletter
Engagement Flow
From first contact to delivery — a simple five-step process
1
Contact
By email, phone, or Zoom.
2
Discovery
Share current state, challenges, and goals.
3
Proposal
Transparent cost, timeline, and risk estimate.
4
Contract
Rapid NDA support.
5
Delivery
Regular updates through completion.
Start with a Free Consultation
Patient, corporate, or membership — first 30 minutes are free.