The World's First AI Agent for Medical Device Clinical Trial Protocols
Reduce protocol design time by 70% and cost by 50% — built for FDA/EMA compliance.
Revolutionizing Medical Device Clinical Trials
MediDraft AI is the world's first artificial intelligence agent specifically designed for creating medical device clinical trial protocols. Unlike pharmaceutical-focused solutions, our platform addresses the unique regulatory challenges faced by medical device developers.
By leveraging advanced AI technology trained on extensive medical device regulatory data, Medidraft dramatically reduces preparation time by 70% and slashes costs by 50%, making global clinical trials accessible even to startups and small manufacturers.
Core Benefits
Time Reduction
Medidraft AI's automation features compress the traditional 6-12 month protocol development cycle to just a few weeks. By analyzing global clinical data and regulatory documents, our AI generates comprehensive drafts instantly, minimizing researcher workload and accelerating trial launch timelines.
Result: Up to 70% reduction in protocol development time
Cost Reduction
Our AI replaces substantial early-stage expenses including data collection, expert consultation, and document preparation. This cost efficiency creates opportunities for resource-constrained medical device companies to compete in global markets without compromising protocol quality.
Result: 30-50% savings on clinical trial preparation costs
Regulatory Compliance
Medidraft AI automatically incorporates requirements from major regulatory bodies including FDA, EMA, PMDA, and MFDS into every document it generates. This enhances approval probability while reducing rework caused by errors or omissions.
Result: Heightened FDA/EMA approval probability with accelerated clearance timelines
Technology
Modular RAG-Based Search & Generation Engine
Our modular architecture enables precision tuning, easy component replacement, and rapid adaptation to regulatory changes. When guidelines evolve, Medidraft updates automatically, ensuring continued compliance.
Device Class-Specific Solutions (I, II, III)
Medidraft is structured to automatically apply the appropriate requirements based on device classification across regulatory bodies. Input your device parameters (country, class, trial objectives, control groups) and receive customized protocols with all mandatory elements, optimal structure, and relevant references.
Proprietary Dataset
Leveraging 730,000+ global clinical trials and 29,000 CRO profiles, we've curated a specialized medical device trial dataset with purpose-built metadata—far beyond what generic pharmaceutical solutions offer.
Social Impact
Empowering Small Medical Device Companies
By reducing financial and time barriers, Medidraft enables startups and SMEs to pursue FDA/EMA-certified clinical trials that were previously accessible only to large corporations with extensive resources. This democratization of clinical trial capability helps innovative solutions reach global markets regardless of company size.
Accelerating Healthcare Innovation
Regulatory automation shortens medical device development cycles across the industry. Faster innovation cycles translate to more breakthrough technologies reaching patients sooner, creating positive ripple effects including new job opportunities in medtech manufacturing and implementation.
Expanding Patient Treatment Access
Every week saved in trial preparation means patients access potentially life-changing treatments earlier. By streamlining the regulatory pathway, Medidraft helps innovative medical devices reach patients who need them most without unnecessary administrative delays.
History & Vision
Vision: "Resolving clinical trial bottlenecks to create a virtuous cycle that provides more patients with treatment opportunities."
Since our founding in 2019, MEDIAIPLUS has consistently earned recognition for innovation at the intersection of healthcare, AI, and regulatory science. From our beginnings as a venture-backed startup to our selection for prestigious programs like MassChallenge and the TIPS Program, we've maintained a laser focus on solving the most critical challenges in medical device clinical trials.
Our growing collection of awards—including the KISA President's Award and Gyeonggi Province Governor's Award—reflects our commitment to developing technology that makes a meaningful difference in healthcare innovation accessibility.
1
2019
MEDIAIPLUS founded
Corporate research institute established
2
2020-2021
KIBO 'Venture Company' certification
KORAIA 'AI Tech Company' recognition
TIPS Program selection
3
2022-2023
Social Venture certification
MassChallenge finalist
Triple award at Youth Entrepreneur Competition
4
2024
AI+Security Demo Day Grand Prize
Governor's Award for Startup Excellence
Media Coverage
Medidraft AI has captured attention across industry publications and mainstream media for its revolutionary approach to medical device clinical trials. Our leadership team regularly contributes expert insights on regulatory AI, clinical trial optimization, and the future of medtech innovation.
Our innovative approach to solving longstanding industry challenges has been featured in specialized publications covering regulatory affairs, medical device development, and healthcare AI implementation. Media inquiries can be directed [email protected].
Intellectual Property & Recognition
Patent Portfolio
MEDIAIPLUS has secured 8+ patents covering essential clinical trial technologies, demonstrating our commitment to innovation and our technological leadership in the field:
  • Keyword Prediction Systems (Patent #10-2318674)
  • Data Matching & Classification (Patents #10-2521961, #10-2521963)
  • Content Output Optimization (Patent #10-2571399)
  • Clinical Visualization Tools (Patent #10-2571400)
  • Advanced Annotation Systems (Patent #10-2591048)
  • Rare Disease Document Similarity Analysis (Patents #10-2619062, #10-2713856)
Awards & Recognition
  • Minister's Commendation for Healthcare Innovation
  • DATA-Stars Awards Excellence Prize
  • Challenge K-Startup Ministerial Award
  • AI+Security Demo Day Grand Prize (KISA President's Award)
  • Gyeonggi Province Governor's Award for Startup Excellence
Schedule Your Personalized Demo
Experience firsthand how Medidraft AI can transform your medical device clinical trial process. Our team of regulatory and AI experts will walk you through a customized demonstration based on your specific device classification and target markets.

What to expect from your consultation:
  • Device-specific protocol generation demonstration
  • ROI analysis for your clinical trial timeline
  • Regulatory strategy recommendations
  • Implementation and integration options
Complete the form to schedule your free consultation. A member of our team will contact you within one business day to confirm your appointment.

Contact
Get in touch with our team for demo requests, partnerships, or general inquiries.
Email: [email protected]
Phone: +82 10-4897-0130
HQ: #456, 815 Daewangpangyo-ro, Sujeong-gu, Seongnam-si, Gyeonggi-do, Republic of Korea
LAB : #469, 815 Daewangpangyo-ro, Sujeong-gu, Seongnam-si, Gyeonggi-do, Republic of Korea

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