実証された成果。現実世界のインパクト。
An orthopedic manufacturer locked into a distributor-tied KLH switched to independent KLH structure mid-portfolio — without losing a month of Korean revenue.
How a European cardiovascular manufacturer secured Korean market authorization across 14 SKUs spanning two device classes — without sequencing them as separate projects.
Aggregated findings from KGMP mock audits at 12 foreign medical device manufacturer sites in 2024. The same 10 issues account for 78% of findings.
How a European Class IIb cardiovascular device manufacturer avoided $200K+ in post-submission rework by integrating MFDS regulatory review into design freeze.
A Korean AI radiology startup achieved MFDS Class III SaMD approval in 5 months — faster than the typical 8–14 month timeline. Here's how the strategy worked.
