最新の業界ニュースとインサイト
EU MDR vigilance reporting uses MIR forms and FSCA notifications under tight timelines. A working guide to EUDAMED submission and multi-state narrative consistency.
2026.06.26
FDA medical device adverse event reporting is well-documented but operationally tricky. A practical guide to Form 3500A, eMDR submission, and reporting timeline judgment.
2026.06.25
Periodic Safety Update Reports under EU MDR are not just documentation — they re-evaluate the benefit-risk balance. A working guide with Korea cross-reference.
2026.06.24
The Device Master Record is where design outputs become production reality. A practical guide to GD&T drawings, 3D CAD, BOM structure, and DFM/DFA review.
2026.06.23
CSV is where medical device QMS rollouts get bogged down. GAMP 5 category-based scoping, Part 11 essentials, and the KGMP/FDA/MDR alignment in one guide.
2026.06.22
Migrating decades of paper and folder-based QMS records into an eQMS is where most rollouts stall. A practical guide with CSV and Korea KGMP audit considerations.
2026.06.21
Korean medical device regulation publishes through four channels, three languages, and irregular cadence. A working monitoring strategy that catches what matters.
2026.06.20
IEC 60601 / 62366 testing for the Korean market has lab-recognition rules and use-environment specifics that catch foreign manufacturers. A working guide.
2026.06.19
Risk management built into design controls produces audit-defensible files at half the rework cost. A practical guide with Korea MFDS / KGMP specifics.
2026.06.18
