Expertise

Medtech & IVD

Yideum Legal Partners possesses a profound understanding of the rapidly evolving regulatory landscape in today's healthcare sector. Our firm swiftly adapts to regulatory changes and anticipates the demands of regulatory agencies, ensuring our responses are not only timely but also strategically aligned with the latest advancements in medical device trends. This approach enables us to effectively meet the intricate requirements of our corporate clients.

We provide legal and strategic advice throughout the entire lifecycle of medical devices and in vitro diagnostic devices (IVD), tailoring our services to each company’s unique characteristics and requirements. Our expertise spans clinical utility and evidence generation, MFDS(KFDA) licensing, market entry strategies through advanced medical technologies, and insurance claims strategies. With skilled legal representation supporting each phase, we ensure that medical devices and IVDs are delivered quickly and securely, enhancing patient access to essential medical innovations.

Additionally, we foster sustainable corporate growth by developing compliance monitoring programs, reviewing distribution contracts, and providing intellectual property consultations to manage regulatory risks and resolve legal challenges during commercialization.

  • Legal Service

    • Corporate and Governance
    • Labor and Employment
    • Data Security, Privacy and IT
    • Healthcare Compliance and Monitorships
    • Litigation and White Collar Crimes & Investigations
    • Patent and Intellectual Property
  • Biz & Commercialization Support

    • Opportunity Prioritization
    • Competitive Landscape Analysis
    • Customer Profiling & Segmentation
    • Business and Revenue Model Review and Advisory
    • Regulatory Strategy & Representation (as an attorney)
    • Market Access and Reimbursement Strategy & Representation (as an attorney)
    • Clinical Utility and Evidence Generation Strategy
    • Integrated HTA and Payer Evidence Planning & Advisory
    • Payer Value Proposition Assessment
    • Market Entry and/or Development Strategy
  • Corporate Growth

    • Corporate Growth Strategy & Advisory
    • Business Unit Strategy & Advisory
    • Corporate Restructuring Advisory
    • Licensing and M&A Advisory and Support
    • Buy and Sell-side Diligence