Import certification · 2020
Class 2 certification
Respiratory & anesthesia devices
Respiratory · anesthesia
Technical file and test data review, first-round deficiency response, manufacturer GMP document support
Certified
RResults
Proven by issued documents.
The actual outcomes of registrations we performed, published within disclosure limits. Client, manufacturer, and filing numbers are masked; full histories and evidence are provided in proposals or under NDA.
- 16+
- Completed MFDS registrations
- Class 1–4
- Scope · completed track record in Class 1–3
- 8+ yrs
- Minimum consultant experience
- 1
- Point of contact — a dedicated PM
R-01Selected Cases
Selected cases
Organized by device category, class, scope of work, and outcome.
KGMP conformity letter · 2020
KGMP conformity
Imaging acquisition device (Class 2)
Imaging · diagnostics
Initial KGMP audit preparation (facility and quality documents), technical file organization, on-site audit support
Conformity granted
Import notification · 2026
Class 1 · import license
Orthopedic supports & splints
Orthopedic · rehab
Import business license application review, facility/quality/filing documents, Class 1 import notification
Filed
Import certification · 2022
Class 2 · IVD
In-vitro diagnostic device
IVD
Performance and clinical performance data review, technical file organization, submission strategy
Certified
Manufacturing certification · 2024
Class 2 · SaMD
Medical imaging analysis software
SaMD · digital
Software V&V documents, cybersecurity checklist, change-approval review response
Certified
Import notification · 2023
UDI registration
Powered medical device
Powered devices
UDI standard code issuance and registration, MFDS reporting and post-market system setup
Registered
R-02Documents
Actual issued documents (masked)
16 masked copies in total. Types and years are read from the original documents; tap any document to enlarge.
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