Medical Device QA/RA Consulting
Covering PMDA, FDA, and CE in one integrated workflow — from strategy and submission to QMS build-up and inspection support.
PMDAFDA 510(k)CE (MDR / IVDR)ISO 13485
500+
Submissions Supported
15+
Years Experience
95%
First-Pass Approval
30+
Countries Covered
Markets We Cover
All three major regulatory regions — Japan, USA, EU
PMDA
PMDA Submission Support
Filing, approval, and certification.
- Medical device filing / approval / certification
- Pharmaceuticals & regenerative products
- GCP / GMP compliance survey
- PMDA consultations (pre-meeting / face-to-face)
FDA
FDA 510(k) / De Novo
US market access regulatory strategy.
- 510(k) submission & clearance
- De Novo classification request
- PMA approval support
- FDA inspection support (QSR / QSIT)
CE
CE Marking (MDR)
EU MDR / IVDR compliance support.
- MDR / IVDR conformity assessment
- Notified Body liaison
- Technical Documentation
- PRRC / Authorised Representative
QMS
QMS / ISO 13485
Quality management system build-up.
- QMS build-up & documentation
- Internal auditor training
- ISO 13485 certification
- Continuous improvement support
Submission Flow
Five steps to enter regulated markets
1
Strategy
Decide market, classification, and pathway.
2
Gap Analysis
Visualize current state vs requirements.
3
Build
QMS, technical documentation, risk management.
4
Submit & Respond
Fast, accurate answers to authority queries.
5
Post-Market
PMS, change notifications, renewals.
Even a strategy chat is welcome
Don’t know where to start? First 30 minutes will clarify direction.