博唯弘展生技股份有限公司
  • 首頁
  • Home
  • 團隊介紹
  • Our Team
  • 技術研發
  • Technology
  • 產品介紹
  • Products
  • 聯絡我們
  • Contact

    PROVIEW-MBD Biotech focuses on smart hydrogels and advanced polymer-based medical materials as its core technologies, integrating material design, process development, and clinical application as the three major RD pillars. The company is committed to transforming innovative technologies into medical products with clinical value, continuously advancing commercialization and international expansion to establish a globally competitive brand in smart materials.
    With safety and efficacy as its RD foundation, the company follows international standards for medical device quality and biocompatibility, building a comprehensive RD framework that encompasses material research, process validation, clinical translation, and market implementation. Through innovative smart materials, PROVIEW-MBD is dedicated to protecting and improving human health.

Material Development

    PROVIEW-MBD Biotech has long been dedicated to the fundamental research and applied development of smart hydrogels and biomedical polymer materials, focusing on molecular structure design, crosslinking mechanism control, and formulation stability analysis.
   The RD team conducts systematic testing based on the ISO 10993 series of biocompatibility evaluation standards, covering cytotoxicity, sensitization, irritation, and degradation behavior to ensure product safety and clinical compatibility.
  On the application side, the company began with anti-adhesion and tissue repair materials and has progressively expanded into drug-release carriers, regenerative medicine scaffolds, and composite materials integrated with cell therapy.
   Through molecular-level material optimization and physicochemical property analysis, PROVIEW-MBD has established a smart materials platform that combines stability with clinical translation potential, laying a solid technological foundation for the next generation of advanced medical devices.

   

Process Optimization

     To ensure stable mass production and consistent product quality, PROVIEW-MBD Biotech has implemented a quality risk management approach, establishing control mechanisms for critical process parameters (CPPs) and key quality attributes (CQAs).
    The team integrates statistical process analysis and process capability validation, gradually forming a traceable and reproducible process standard. In accordance with ISO 13485 medical device quality management systems and ISO 14971 risk management standards, the company strictly controls raw materials, equipment, and production environments to maintain process stability and product consistency.
   Through process scale-up, pilot validation, and modular technology integration, PROVIEW-MBD has built a complete framework from RD prototyping to mass production transfer, supporting product manufacturing and international certification applications.

  

Clinical Translation

   PROVIEW-MBD Biotech takes a clinically driven approach, integrating innovative materials into practical medical applications. The RD and regulatory teams jointly plan preclinical studies, product risk analyses, and clinical trial designs to ensure product safety and evidence-based efficacy.
   The company has experience in the regulatory development and registration of Class III medical devices, supporting end-to-end project management from preclinical research, sample preparation, and technical documentation to clinical trial execution.
   In collaboration with medical centers and professional CRO partners, clinical studies are conducted in accordance with ISO 14155 clinical investigation standards and the regulatory requirements of TFDA and the U.S. FDA, ensuring that all products meet international standards for safety and efficacy.
   Through vertical integration from RD, process development, and clinical validation to commercialization, PROVIEW-MBD continues to drive material innovation, clinical evidence generation, and industrialization, driving forward its mission to safeguard human health through smart biomedical materials.

  • 首頁
  • Home
  • 團隊介紹
  • Our Team
  • 技術研發
  • Technology
  • 產品介紹
  • Products
  • 聯絡我們
  • Contact