Zhongguancun Shuimu Medical Technology

What Zhongguancun Shuimu Medical Technology does

Zhongguancun Shuimu Medical Technology is a Beijing-based, privately-held medical device services group founded in 2017 that operates what it describes as the world's first full-value-chain one-stop platform for medical device industrialization. Through seven specialized subsidiaries — Shuimu Medical (inspection and testing), Chengdu Shuimu (engineering R&D and design evaluation), Shuimu Jingzhi (market access, clinical training, and animal experiments), Shuimu Jingchuang (clinical trial CRO), Shuimu JiHeng (IVD lifecycle services and reference/control materials), Shuimu Jinsheng (CDMO manufacturing), and Shuimu Lingrui (life-science digital operations and radiotherapy physics QC) — the group offers end-to-end services spanning engineering R&D, inspection and testing, clinical trials, regulatory registration, CDMO manufacturing, and post-market access. Its inspection and testing platform holds dual CMA and CNAS certifications, with 694 certified standard methods covering 8,278 testing items and 95%+ coverage of active medical device and IVD testing projects, supported by a 3,500 sqm Beijing laboratory with EMC, electrical safety, reliability, packaging, software, and IVD labs plus 3m/10m semi-anechoic chambers.

The company targets primarily medical device manufacturers and IVD companies in China, with secondary focus on advanced device segments (radiation therapy, surgical robots, AI medical devices, digital therapeutics) and medical device startups. Revenue is generated through B2B professional-services and managed-services fees across inspection/testing, clinical CRO, CDMO, IVD reference materials, and market access engagements, with no public pricing. Distribution runs through direct enterprise sales backed by a 25+ city national service network, industry-conference presence (e.g., CMEF), the Shuimu Academy training platform, and an online service ordering system (dlp.zgcsm.cn). The group has raised three funding rounds, including a Series B of several hundred million RMB in September 2025 led by Hongyi Investment and Guoju Venture Capital, with capital earmarked for service platform expansion and national network strengthening.

Name

Zhongguancun Shuimu Medical Technology

Legal name

北京中关村水木医疗科技有限公司

Website

https://zgcsm.cn

Company type

Private

Founded year

2017

Operating status

Operating

Headcount range

11–50 employees

Short description

Zhongguancun Shuimu Medical Technology is a Beijing-based private medical device services group operating a one-stop platform spanning engineering R&D, inspection and testing, clinical CRO, CDMO, IVD reference materials, and market access for medical device manufacturers and IVD companies across China.

Ownership category

akta.pro rank

Product category

Medical Device Testing and Certification Services

NAICS

Testing Laboratories and Services (541380), Surgical and Medical Instrument Manufacturing (339112), Navigational, Measuring, Electromedical, and Control Instruments Manufacturing (33451)

SIC

Services-Testing Laboratories (8734), Surgical & Medical Instruments & Apparatus (3841)

akta.pro industry

PRIMARYHLAGAKAD

Quality Management Systems (QMS) & GxP Documentation

Healthcare & Life Sciences/Life Science Tools & Services (CRO/CDMO/Lab Services)/Regulatory Affairs, Quality & Compliance Services (GxP)

SECONDARYHLACAMAH

Quality Management & Regulatory Compliance (CLIA/CAP/ISO) for Labs

Healthcare & Life Sciences/Digital Health & Health IT/Laboratory Information Systems (LIS/LIMS) & Pathology Informatics

SECONDARYHLAGAKAL

Quality Engineering & Risk Management (ICH Q9/Q10, validation, change control)

Healthcare & Life Sciences/Life Science Tools & Services (CRO/CDMO/Lab Services)/Regulatory Affairs, Quality & Compliance Services (GxP)

SECONDARYHLAGACAG

Clinical Trial Monitoring Support (On-site/Remote)

Healthcare & Life Sciences/Life Science Tools & Services (CRO/CDMO/Lab Services)/Clinical Trial Services & Site Management (SMO)

SECONDARYHLAGAKAI

Clinical Quality Assurance (GCP QA, TMF/QMS oversight)

Healthcare & Life Sciences/Life Science Tools & Services (CRO/CDMO/Lab Services)/Regulatory Affairs, Quality & Compliance Services (GxP)

Keywords

• Medical device testing
• Clinical trial services
• IVD reference materials
• Medical device CDMO
• Regulatory compliance services

Headquarters

HQ city

Beijing

HQ country

China

HQ region

Asia

Offices28 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Infrastructure, Technology or R&D, Operations, Marketing or Sales

Revenue model

1. Inspection & Testing Services: Third-party testing and certification services for medical devices including active medical devices, in vitro diagnostics, and some passive device testing. Services cover electromagnetic compatibility, electrical safety, reliability, packaging, software testing, and IVD testing. Revenue is generated through testing service fees charged to medical device companies.
2. Clinical Trial CRO Services: Clinical trial contract research organization (CRO) services covering medical device clinical trials across areas including radiation therapy equipment, medical robots, IVD, aesthetic medicine, cardiovascular/neural intervention, and digital therapeutics. Covers clinical trial design, execution, monitoring, and reporting.
3. CDMO Manufacturing Services: Contract development and manufacturing organization services for medical devices, including 万级 and 十万级 cleanrooms, sterile verification testing center, and R&D production platform. Covers full product lifecycle from concept verification, R&D design, pilot testing, to registration system support.
4. IVD Standard/Control Products: Research, development, production and registration services for IVD calibrators, control products and reference materials. Provides customization, R&D, production and registration services for domestic and international IVD reagent products.
5. Medical Device Market Access Services: Post-market access services including clinical application evaluation, medical insurance/pricing entry, medical training, and animal experiments. Includes 12 fully simulated real clinical environment operating rooms and 500+ real training devices.

Go-to-market motion1 record

Distribution channels2 records

Marketing channels6 records

Core offering

Zhongguancun Shuimu Medical Technology operates China's first privately-established third-party medical device inspection and testing institution, providing an integrated full-lifecycle one-stop service platform covering engineering R&D, inspection and testing (EMC, electrical safety, reliability, packaging, software, IVD), clinical trial CRO services, CDMO manufacturing, registration support, and post-market access for medical device and IVD companies. Services are delivered under CMA and CNAS certifications across a nationwide network of 25+ Chinese cities.

Product overview

Zhongguancun Shuimu Medical Technology Service Group operates a portfolio of seven specialized subsidiaries forming a one-stop service platform for medical device industrialization. The platform covers the full lifecycle of medical devices: engineering R&D (via 成都水木/器械设计与评价平台), inspection and testing (检验检测服务平台/水木医疗 with CMA, CNAS, and A2LA certifications covering 95%+ of active medical devices and IVD products), animal studies (水木精智), clinical trial CRO services (水木菁创), IVD product lifecycle services (水木济衡), CDMO manufacturing (水木金昇), digital operations for radiotherapy (水木凌瑞), and market access support (水木精智市场准入平台). The group also operates the 七星孵化器 (Seven Star Incubator, founded 2023) to help companies transition from innovation concept to productization. Together these subsidiaries enable end-to-end services from concept through commercialization under the mission 'Make medical devices easy to use for everyone in the world'.

Differentiator

Problem solved

Functional benefit

Brands

• 七星孵化器 (Seven-Star Incubator): 中关村水木医疗七星孵化器成立于2023年，可助力企业高效实现从创新概念到产品化的转换。
• 水木学院

Products and services

• Inspection and Testing Service Platform (检验检测服务平台) Third-party inspection and testing services for medical devices including active devices and IVD reagents, covering electromagnetic compatibility, electrical safety, reliability, packaging, software testing, and IVD testing with dual CMA/CNAS certifications. Designed for medical device manufacturers requiring regulatory testing for product registration.
• Medical Device Design and Evaluation Platform (器械设计与评价平台 / MDDE) Engineering R&D and reliability evaluation services including software/hardware auxiliary R&D, reliability analysis, test verification, and application evaluation for high-end medical devices such as MRI, radiation therapy equipment, and surgical robots. For medical device companies needing early-stage design and reliability support.
• Medical Device Clinical Trial CRO Platform (医疗器械临床试验CRO平台) Clinical trial contract research organization (CRO) services for medical devices across areas including radiation therapy equipment, medical robots, IVD, aesthetic medicine, cardiovascular/neural intervention, and digital therapeutics. Covers trial design, execution, monitoring, and reporting. For medical device companies needing clinical evidence for registration.
• IVD Full Lifecycle Service Platform (IVD产品全生命周期一站式服务平台) Full lifecycle IVD product services including R&D design, quality management system establishment, CDMO full-process services, regulatory policy interpretation, and third-party indoor quality control products (calibrators, controls, reference materials). For IVD reagent manufacturers needing end-to-end support and standard products.
• Medical Device One-Stop CDMO Incubation Platform (医疗器械一站式CDMO孵化平台) Contract development and manufacturing organization (CDMO) services across all medical device categories, providing concept verification, R&D design, pilot testing, and registration system support with Class 10,000 and Class 100,000 cleanrooms and sterile verification testing center. For medical device companies needing manufacturing scale-up.
• Life Science Digital Operations Platform (生命科学产业数字化运营平台 / DOP-LS) Radiation therapy physics quality control services for gamma knife, accelerator, proton, and heavy ion systems, including CMA-certified testing reports, tumor radiotherapy discipline setup, third-party quality control products, expert technical support, and remote target delineation. For hospitals and radiotherapy centers.
• Medical Device Market Access Service Platform (医疗器械市场准入服务平台) Post-market access services including clinical application evaluation, medical insurance/pricing entry, medical training, and animal experiments, with 12 fully simulated real clinical environment operating rooms, 500+ real training devices, and a 2,000 sqm international standard large animal experiment center. For medical device companies needing clinical evaluation and training infrastructure.

Quantifiable outcome

• 95%+ coverage of active medical device and IVD testing items
• +2 more outcomes

Segments4 records

Ideal customer profiles4 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature6 records

Partnerships

One partnership is on record.

• University of Electronic Science and Technology of China (电子科技大学)coreStrategic or Co-development PartnerEstablished the 'Shuimu Medical - University of Electronic Science and Technology of China Joint Laboratory' for medical device auxiliary R&D and reliability innovation. The partnership enabled the co-development of a medical device reliability evaluation platform for MRI, radiation therapy equipment, surgical robots, and other high-end medical devices. The project was recognized as a typical case in the 2022 China Higher Education Association 'School-Enterprise Cooperation Double Hundred Plan'.

Scale indicators6 records

Recent moves8 records

Expansion highlights7 records

Direct peers

• Bureau Veritas: Global testing, inspection, and certification group with a Consumer Products / Health & Beauty medical device testing line. Competes for medical device compliance and EMC testing engagements, particularly for cross-border manufacturers.
• SGS: Global testing and certification leader with medical device testing services covering EMC, electrical safety, and regulatory testing. Directly competes in third-party medical device testing and shares the international-customer overlap narrative.
• Intertek: Global ATIC (Assurance, Testing, Inspection, Certification) company with medical device testing services. Direct peer in regulatory testing, EMC, and electrical safety testing for medical devices.
• TÜV SÜD: Major global testing, inspection, and certification company with a dedicated medical device practice offering EMC, electrical safety, and product certification services. Direct competitor to Shuimu's Inspection & Testing platform for medical device manufacturers seeking international and domestic certification.
• Centre Testing International (CTI): One of China's largest private third-party testing companies with broad medical and life sciences testing capabilities. Most direct Chinese competitor for medical device inspection and testing scale, with comparable nationwide footprint.
• Pony Testing International (谱尼测试): Major Chinese third-party testing organization with diversified medical/healthcare testing services. Competes directly in CMA-certified medical device and IVD testing capacity in China.
• Eurofins Scientific: Global testing services group with dedicated medical device testing capabilities. Competes in third-party device testing and IVD analytical services, particularly for international manufacturers seeking one-stop compliance support.

Broad incumbents

• Pharmaron: Chinese-headquartered global CRO/CDMO offering integrated chemistry, biology, and manufacturing services. Broad incumbent competing for medical device and IVD development/CDMO work with comparable one-stop positioning.
• WuXi AppTec: Global CRO/CDMO leader headquartered in China with broad test-to-manufacturing service offerings. Larger, established competitor across CRO and CDMO with broader international reach and deeper commercial scale.
• Hangzhou Tigermed: China's leading clinical contract research organization with significant medical device clinical trial operations. Direct peer for Shuimu Jingchuang's medical device CRO platform, particularly in radiation therapy, IVD, and digital therapeutics trials.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat6 records

Key risks6 records

Key highlights6 records

Customer concentration

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles3 records

Subsidiaries9 records

Funding overview

Funding rounds3 records

Investors8 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Zhongguancun Shuimu Medical Technology