Markets
Explore end-to-end regulatory and market authorization services by country and lifecycle stage.
Establish device classification, required testing, timeline, and budget using MFDS database analysis.
1:1 review of DHF/technical files against MFDS standards to eliminate deficiency risks upfront.
Pre-inspection audit against latest MFDS criteria to resolve facility and documentation gaps.
Secure trial exemptions through substantial equivalence and systematic reviews.
Diagnose reimbursement eligibility, nHTA pathways, and price ceilings before filing.
Establish SaMD classification and PCCP frameworks under the Digital Act.
End-to-end management from Class 1 notification to Class 4 safety and efficacy review.
Class 2 31-document packaging and Class 3–4 joint on-site inspection representation.
Turnkey IEC 62304 lifecycle files, AI clinical validation, and SBOM packaging.
Analytical validation and hospital-based clinical performance evaluations.
Electrical safety, EMC, and biocompatibility testing protocol design and lab coordination.
Turnkey usability engineering files, formative studies, and clinical summative evaluations.
SBOM compilation, threat modeling, and cybersecurity submission packages for MFDS review.
Coverage determination, economic evaluation, and Korean hospital fee code setup.
Independent legal representation decoupled from distributors to preserve license sovereignty.
License transfers upon distributor change and regulatory due diligence for MedTech M&A.
Compile safety, efficacy, and import records 8 months prior to expiry for seamless renewal.
Continuous change classification and remediation of historical unnotified design alterations.
Adhere to MFDS 7/15/30-day adverse event reporting deadlines and manage rapid recall protocols.
Monthly NIDS UDI supply filings, KMDIA advertising pre-clearance, and monthly intelligence.
