henry-1981
@henry-1981
2 Skills
0 Total Stars
March 2026 Joined
Public Skills
aria-determination
by henry-1981
Medical device determination skill for FDA, EU MDR, and MFDS regulations. Evaluates whether a product qualifies as a medical device. Use for device status evaluation and regulatory scope determination.
aria-fair-competition
by henry-1981
Korean medical device fair-competition review and drafting skill based on the KMDIA Fair Competition Code (의료기기 거래에 관한 공정경쟁규약). Evaluates activities against the Code, provides traffic-light guidance (GREEN/YELLOW/RED), and supports review or drafting output for internal approval workflows.