NTeam
One team owns the whole process.
Representative PM Daye Yoon personally leads every project from quote review to certificate issuance, with specialists joining by device category, class, and stage. Your point of contact stays the same from start to finish — requirements don't leak, and accountability doesn't scatter.
N-01Roster
The team
The representative PM leads, and the experts below are assigned by device category and stage. Real names and current employers appear only with consent; detailed credentials are shared at the proposal stage.
Founder & Representative PM
Daye Yoon
- RA/QA
- Class 1–3
- SaMD
- KGMP
- FDA/CE
Hands-on across the full cycle: regulatory strategy, technical file writing, GMP audit response, and FDA/CE documentation. Leads scheduling and communication on every project, grounded in Class 1–3 registration practice.
RA · Technical files
Initial KGMP audit and import certification for Class 2 imaging/diagnostic devices; FDA usability and cybersecurity documentation. Korean SaMD approval and FDA Pre-Sub responses.
GMP · Import structure
On-site KGMP audits at Chinese manufacturing sites; import certification structure design. KGMP completed across powered nebulizers, electromagnetic generators, laser surgical devices, and more.
Overseas registration
Thailand Class II and Russian registration for an electromagnetic generator. FDA 510(k) renewal for a laser surgical device; CE MDD→MDR transition technical files.
PM leadership
A single-PM system from quote review to technical file submission, MFDS deficiency response, and certificate issuance — including specialist assignment.
N-02Advisory Experts
When licensed professionals step in
Registration problems often arrive attached to contract, customs, and corporate-registry problems. At each of those points, a licensed professional joins the same project — and your point of contact remains the PM.
Legal
Attorney
When — structuring L&I or supply contracts, or preventing disputes at the contract stage
Legal advice on medical device import contracts, transaction structures, and dispute prevention.
Customs
Customs broker
When — clearance is held up, or HS codes, duty rates, and FTA calls are needed
HS codes, duty rates, FTA, import clearance, requirement verification, clearance-hold response.
Administrative
Administrative agent
When — Class 1–2 registrations run alongside administrative procedures
Class 1–2 device registration, KGMP, import business licensing, cosmetics registration.
Corporate Registry
Judicial scrivener
When — company formation or registry changes precede market entry
Company incorporation and registry-change filings, corporate registry advice.
Marketing
Marketing partner
When — the license is issued and the product needs channels
Websites, brand communication, product pages, online channel operations.
N-03Project Consultants
External advisory experts · project consultants
External specialists across RA/QA/GMP/clinical/SaMD/IVD are assigned by device category and class. Listed anonymously or within consented disclosure.
Consultant A · 17 yrs
Aesthetic / energy-based RA Lead
Class 2–3 energy-based devices, surgical devices, patient monitors, IVD
Consultant B · 8 yrs
Import RA/QA/MA Lead
Import and manufacturing regulatory strategy, overseas site management, KGMP/GIP/GSP
Consultant C
Import QA/RA Senior
ISO 17025, ISO 13485/GMP, Class 1–3 technical files, KC
Consultant D · 13 yrs
Dental device RA/QA Lead
Dental device registration, CE/GMP, biological safety evaluation
Consultant E · 15 yrs
RA/SaMD · Clinical Senior
Class 2–4, CE MDR, FDA 510(k), SaMD, clinical trial plan approval
Consultant F · 21 yrs
Class 4 device RA/QA Lead
Class 4 devices, CE MDR, GMP/ISO 13485, quality systems
Consultant G · 16 yrs
Clinical development / Medical writing Lead
Protocol/CSR/IB/ICF/CRF; CRO, hospital, statistics/DM collaboration
Consultant H · 8 yrs
QA/RA Senior · GMP/ISO
ISO 13485, KGMP/CE/MDR, SaMD, validation, PMS/PMCF
Consultant I · 9–10 yrs
IVD RA/QA Lead
IVD MFDS, CE IVDD/IVDR, WHO EUL/PQ, FDA EUA
Consultant J · 14 yrs
Domestic RA Lead · high-risk
Class 1–4 Korean registration, stents/implants, KGMP, UDI
External advisory experts and project consultants are independent professionals, not employees of CLARE Partners, participating on an advisory or contract basis per project. Services of licensed professionals — attorneys, customs brokers, administrative agents, judicial scriveners — are performed under their own independent legal responsibility, under separate engagement or advisory agreements where needed.
Just send the product details.
We do the reviewing.
We pre-review device class, required pathway, and data readiness free of charge, and reply within 1 business day. No sign-up.