Biomedical Science

Biomedical Research and Medical Device Development

1. Biomedical Research

UniSoul Friends Bio conducts biomedical research based on experiments, clinical trials, and literature with the goal of developing advanced biotechnology for human health improvement through multi-layered research strategies. This research encompasses a full-cycle research ecosystem including drug efficacy verification, disease mechanism identification, and clinical applicability evaluation, providing next-generation medical solutions through the integration of data-based precision medicine and innovative technologies.

#01

Experimental Research

  1. In vivo model-based drug efficacy and toxicity evaluation
  2. Protein-Protein Interaction and pathway analysis
  3. Genomics/Transcriptomics-based analysis
  4. Omics integrated analysis platform development

#02

Literature-Based Research

  1. Scoping Review
  2. Systematic Review & Meta-analysis
  3. Real-World Evidence-based literature research
  4. Cohort-Based Literature Review
  5. Comparative analysis of domestic and international guidelines
  6. Clinical Practice Guideline (CPG) development research

#03

Clinical Research

  1. Randomized Controlled Trials
  2. Single-group pre-post comparison studies
  3. Prospective observational studies
  4. Multi-center clinical trials
  5. Patient-centered clinical research
  6. Economic and policy-linked clinical studies

2. Medical Device Development Research

UniSoul Friends Bio operates a full-cycle support system for the development of innovative medical devices covering both diagnostic and therapeutic areas. From planning and design to prototype production, performance evaluation, clinical trials, regulatory approval, and commercialization, we conduct all processes through our internal research infrastructure. We also provide support for medical device certification, new medical technology registration, patent acquisition, and technology transfer to achieve practical commercialization. In particular, we aim to develop and expand next-generation smart diagnostic and therapeutic devices through the integration of Traditional Medicine, modern conventional medicine, and digital health technologies.

#01

Commercialization Infrastructure and Practical Strategy Support

  1. Medical device certification support
  2. New medical technology registration support
  3. Intellectual property rights acquisition
  4. Technology transfer and joint commercialization

#02

Diagnostic Medical Device Development and Support

  1. Review of medical device regulations
  2. Material standard compliance testing and electrical safety testing support
  3. Patent application and technical documentation support
  4. GMP-based quality management system design consultation
  5. Medical device clinical research design and institutional connection support

#03

Therapeutic Medical Device Development and Support

  1. Pre-clinical safety and efficacy test design and analysis support
  2. Medical device regulatory approval support
  3. New medical technology registration promotion support

Related Achievements

Through our expertise in medical device development, we help clients navigate complex regulatory procedures with clarity.

1. Medical Device Development Research - Diagnostic Medical Device Development and Support

(1) Contact Angle Measurement Technology In Vitro Diagnostic Medical Device Development Research (4th year)

  • Medical device prototype development consulting and clinical trial consulting
  • Ongoing stage-by-stage medical device regulatory approval procedure consulting and research support

(2) Next-generation Pain Pulse Measurement Device Development Research

  • Republic of Korea Food and Drug Administration medical device regulation consulting
  • Basic design of clinical research according to Institutional Review Board regulations and preparation for clinical trial institution connection

2. Medical Device Development Research - Therapeutic Medical Device Development and Support

Digital-based Moxibustion Device Development Research

  • Pre-clinical safety and efficacy test design and analysis support
  • Republic of Korea Food and Drug Administration medical device regulatory approval strategy development
  • New medical technology registration promotion plan establishment