Standard Medical Devices Files IPO Prospectus: Empowering Over 3,000 Clients and Facilitating Approval of 1,000+ Products

In recent years, driven by the booming development of the medical device industry, growing demand for innovative R&D, and supportive policies, an increasing number of enterprises and institutions have opted for one-stop service platforms to accelerate product time-to-market and enhance market competitiveness. As a result, the market size of one-stop service platforms for medical devices in China has demonstrated a trend of rapid growth.

Among them, the Medical Device Business Division of STANDARD GROUP (hereinafter referred to as “STANDARD GROUP”) has been deeply engaged in providing one-stop services for medical devices.

STANDARD GROUP is a comprehensive high-tech service enterprise centered on the biopharmaceutical and life sciences sectors, with deep expertise in integrated trade, ecological environment, and innovative services. It is recognized as a National High-Tech Enterprise and a Shandong Province Gazelle Enterprise. The Group has established a Life Sciences Business Unit (hereinafter referred to as “STANDARD Life Sciences”), which provides services such as safety technical specification testing, human efficacy testing, registration and filing inspections, and outsourced scientific research in the fields of medical devices, daily chemicals, special foods, and life science research.

Among these, medical devices constitute a core business of Standard Life Sciences, which has established a dedicated Medical Device Division (hereinafter referred to as “Standard Medical Devices”). Since its establishment in 2019, Standard Medical Devices has been focusing on testing and R&D services in the medical device sector, offering comprehensive solutions that span product design consultation, regulatory submission, testing and certification, and market access strategy, thereby covering all stages of the medical device lifecycle.

STANDARD GROUP Headquarters Building

STANDARD Medical Devices’ one-stop service platform provides tailored solutions based on customers’ specific needs, helping them effectively shorten product time-to-market and reduce compliance risks.

Specifically, the platform’s services cover both active and passive medical devices, offering one-stop solutions such as preclinical large-animal studies, safety assessments, product testing and sterilization process validation, and biocompatibility testing. Through its service practice, STANDARD Medical Devices has established outstanding, cross-disciplinary, and comprehensive service capabilities, which are underpinned by a strong professional team.

STANDARD Medical Devices has established a professional testing and R&D team of over 400 members, with 40% holding master’s or doctoral degrees. Among them, technical experts and testing certification engineers possess an average of more than ten years of industry experience.

Optoelectronic Laboratory for Active Medical Devices

Physicochemical Laboratory for Non-Active Medical Devices

 Preclinical Large Animal Studies for Medical Devices

STANDARD GROUP Safety Assessment Center

Currently, STANDARD Medical Devices holds national-level CMA and CNAS accreditations. Its laboratory facilities cover a total area of over 24,000 square meters. To date, the platform has obtained accreditation for more than 450 testing items, covering over 5,000 testing parameters, thereby meeting the testing and R&D needs for various medical device products.

Taking biological evaluation and preclinical studies of medical devices as an example, STANDARD Medical Devices offers customized preclinical animal testing services. Leveraging a diverse range of animal species and models, along with a professional technical team, we provide comprehensive tailored solutions to our clients. Currently, STANDARD Medical Devices has designed and constructed over 20,000 square meters of laboratory animal facilities in strict compliance with international standards and national regulations, holding licenses for the use of various categories of Specific Pathogen Free (SPF) and conventional-grade laboratory animals. Additionally, STANDARD Medical Devices holds a Radiation Safety License and is qualified to operate radiological equipment.

To enhance service quality, the platform has introduced advanced experimental equipment and technologies, covering high-precision testing, automated analysis, and intelligent animal husbandry management, thereby ensuring more accurate and reliable experimental data. In terms of instrumentation, the platform is equipped with over 500 sets of advanced instruments, including Q-TOF mass spectrometers, HPLC systems, fully automated biochemical analyzers, fully automated hematology analyzers, orthopedic fatigue testing machines, and high-precision optical measuring instruments, providing robust hardware support for safety evaluations across various industries.

STANDARD GROUP Safety Assessment Center - X-ray Computed Tomography (CT) Equipment

STANDARD GROUP Safety Evaluation Center - X-ray Computed Tomography (CT) Equipment

STANDARD GROUP Safety Evaluation Center - SPF Rat Animal Facility

STANDARD GROUP Safety Assessment Center - Beagle Dog Animal Facility

In recent years, the continuous emergence of new technologies and concepts in the medical device industry has raised higher demands for the responsiveness and innovation capabilities of one-stop service platforms. Seizing this opportunity, STANDARD GROUP has consistently invested substantial resources in research and development and technological upgrades, thereby creating greater possibilities for customers’ product innovation and market expansion.

In emergencies, service response speed often significantly impacts a company’s survival, development, and market competitiveness. During the pandemic, a biotechnology company urgently needed to expand its production capacity for in vitro diagnostic (IVD) test kits. STANDARD Medical Devices promptly activated its emergency response mechanism, achieving a several-fold increase in production capacity within a short period by optimizing production line layout and process workflows.

Through years of accumulation, STANDARD Medical Devices has amassed substantial industry resources and established an extensive cooperation network spanning both domestic and international markets. Currently, the platform has forged close partnerships with numerous industry associations, including the China Association for Medical Devices Industry, the Medical Device Branch of the China Food and Drug Promotion Association, and the Shandong Medical Device Industry Association. Furthermore, the platform maintains strong collaborations with many overseas enterprises and international certification bodies, such as TÜV AUSTRIA, USB Certification (You Sili), and Eurofins Scientific. This enables the platform to provide clients with rapid and accurate policy interpretations and guidance on international market access.

Meanwhile, STANDARD Medical Devices is rooted in technological R&D and has jointly established an open innovation platform with multiple universities, research institutes, and corporate R&D teams. This initiative fosters exchange and collaboration between academia and industry, accelerates the application and commercialization of new technologies and materials, and reduces R&D time and costs.

For example, in terms of collaboration with universities and research institutes, STANDARD Medical Devices has jointly established the “Shandong Provincial Engineering Research Center for Tissue Rehabilitation Materials and Devices” with Rehabilitation University and the Shandong Institute for Medical Device and Drug Packaging Inspection; it is also cooperating with Ocean University of China on industry-academia-research projects and scientific research platform development in the pharmaceutical field.

In terms of collaborative R&D efforts, the platform has established joint laboratories with internationally renowned companies such as Thermo Fisher Scientific and Agilent Technologies. Meanwhile, STANDARD Medical Devices offers end-to-end collaboration options spanning from R&D to production, including risk-sharing models designed to reduce initial corporate investment and accelerate product time-to-market.

STANDARD - Thermo Fisher Joint Laboratory

STANDARD-Agilent Joint Laboratory

In terms of service layout, STANDARD Medical Devices’ one-stop service platform leverages the robust resources of STANDARD GROUP to establish a comprehensive and efficient service network across China, with strategic emphasis on four key hub cities: Tianjin, Qingdao, Suzhou, and Guangzhou.

As of now, STANDARD GROUP has provided testing, analysis, and R&D services to over 3,000 medical device enterprises and institutions, successfully facilitating market approval for more than 1,000 medical device products.

Regarding future plans, Xiao Yan, General Manager of STANDARD GROUP’s Life Sciences Business Group, stated that the company will continue to strengthen core technology R&D and optimize service processes to shorten the time required for clients’ products to go from development to market launch. Meanwhile, it will enhance regulatory consulting services, closely follow the latest policy changes both domestically and internationally, and help clients rapidly adapt to regulatory requirements. “We will continue to deepen our market presence, strengthen collaborations with medical institutions, universities, and research institutes, and expand our service network to provide higher-quality services and support for innovation in China’s medical device industry.”