RamiMed (Regulatory Affairs + AI + Medical Device) is a startup developing an AI-based medical device regulatory review automation platform. It was founded by CEO Joyoung Choi (33)
Based on her eight years of experience as a medical device reviewer at the Ministry of Food and Drug Safety (MFDS) and as the head of RA (Regulatory Affairs) at a medical device import company, Choi developed a platform that automates the review and preparation of regulatory and insurance registration documents. "Our goal is to help startups and small and medium enterprises prepare authorization documents on their own without having to pay for expensive consulting services," said Choi.
"To sell medical devices, you must obtain authorization and permission from the MFDS and register the product with the Health Insurance Review & Assessment Service (HIRA) (insurance registration), depending on the product, and this process takes an average of two years or more. Reviewing dozens to hundreds of authorization documents and preparing civil petitions is a significant time and cost burden for companies. RamiMed is developing a platform to solve these problems. Users simply upload files to the website, and AI extracts keywords and automatically completes regulatory submission forms."
Choi said, "With the implementation of a five-year license renewal system starting in 2024, this solution will greatly improve work efficiency in the medical device industry at a time when manpower and costs are increasing."
"The logic of this service is not simply to review or summarize documents, but it is designed from the perspective of the regulatory authorities. We implemented logic based on 105 high-risk medical device review cases handled by the MFDS. I have also incorporated my five years of hands-on experience as a regulatory affairs specialist at a medical device import company—covering the full product lifecycle, including authorization, insurance registration, and renewal—into RamiMed."
Another strength of RamiMed is its price competitiveness. RamiMed’s AI-based service is priced at just one-fifth the cost of traditional regulatory consulting services.
In addition, it is clearly different from existing training and consulting companies. "We can provide practical support that was impossible with existing education and consulting services. Existing lectures and training were limited to providing theoretical guidelines and did not support practical tasks such as reviewing test reports for each product or preparing regulatory submission forms. Based on uploaded documents, RamiMed analyzes important items for each product, automatically verifies compliance with regulatory requirements, and then creates customized regulatory submission forms. RamiMed's strength lies in identifying bottlenecks in the work of practitioners and resolving them with automation tools to support practical capacity building."
RamiMed is in direct contact with medical device importers and manufacturers through one-on-one B2B sales based on its representative's network and has secured two letters of intent for service provision.
"We are also entering the B2C market by targeting new RAs and related professionals through lectures on the medical device industry and networking activities with practitioners. Through this process, we induce a cycle where initial customer acquisition leads to repeated use, and as employees personally experience the service, it is adopted as a B2B subscription system within their companies. Going forward, we plan to strengthen our performance-based marketing strategies focused on reducing registration failure rates and costs, rather than simple viral marketing."
What made CEO Choi decide to start a new company? "While working at the MFDS and an importing company, I realized that the process of obtaining authorization and permission for medical devices and registering them for insurance relied too heavily on manual labor. Most medical device companies have only one or two people on their RA team, which makes it difficult to smoothly transfer work and systematically accumulate expertise. The introduction of the five-year periodic medical device license renewal system in 2024 has led to a sharp increase in demand for regulatory affairs specialists, making it extremely challenging for companies in the medical device industry to secure enough qualified staff. I have a tendency to be obsessed with fundamentally solving such inefficiencies. In the past, I have improved work processes within my company through the introduction and development of programs, such as automating pay slips, digitizing annual leave management, and improving collaboration systems. I didn't just stop at ideas but collected actual data, analyzed it, and implemented solutions before starting my business."
Regarding future plans, Choi said, "We will complete an AI document automation tool specialized for bone transplant products by the end of 2025." In 2026, we will expand to all medical device items, and from 2027, we will introduce a price prediction model for insurance coverage, to grow into a service that handles everything from authorization and permission to sales strategies."
Founded: pre-startup stage
Main business: AI-based medical device regulatory review automation platform
Achievements: Awarded the Minister of SMEs and Startups Prize (Excellence Award) at the 26th Women’s Startup Competition; Selected as a company to carry out a team building support project for middle-aged people in 2025; Selected as a tenant company of Kyung Hee University Campus Town; Passed the final round of Kwangwoon University's Idea Camp; Passed the final round of “K-Startup 2025 Startup Storytelling Video;” and Secured two PoCs during the preliminary startup period
reporter jinho lee
jinho2323@hankyung.com