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OBM / ODM / Tech Transfer

OBM / ODM Technology Services

Over 30 years in portable electrochemical biosensing — one-stop OBM / ODM / CDMO services from product design and mass production to global clearance and turnkey technology transfer.

With over 30 years of expertise in portable electrochemical multi-functional biosensors, HMD BioMedical delivers vertically integrated manufacturing capabilities spanning biochemistry, medical engineering, precision mechanics, electronics, and firmware. Centered at our facility in Hsinchu, we offer comprehensive OBM, ODM, and technology-transfer services — from product design and automated mass production to global supply-chain management, international regulatory clearance, packaging, and complete turnkey technology transfers. Backed by over 70 international patents, HMD ensures supreme data fidelity and strict internal compliance.

Private-Label & Integrated CDMO Services

Private-Label & Integrated CDMO Services

With our state-of-the-art facility in Hsinchu, Taiwan, serving as our global core hub, HMD possesses powerful vertical integration capabilities across biotechnology, medical electronics, and software. Harnessing our 30-year biosensor heritage, we deliver comprehensive CDMO services from initial development to high-efficiency mass production, empowering clients to establish sustainable market leadership.

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Production Capacity

Production Capacity

We deliver an industry-leading Turnkey Tech Transfer program, supplying core semi-finished goods (custom enzyme-coated strip blanks / CPE Strips, and pre-calibrated core circuit boards / Meter PCBA) together with complete assembly and packaging SOPs, enabling clients to localize manufacturing and bypass import tariff barriers.

Core technology and local manufacturing have been deployed extensively across Brazil and North Africa, with steady partnerships in Canada, plus a proven CDMO track record for medical-center-grade Point-of-Care (POCT) glucose systems. Across the Indo-Pacific, our four-in-one platform (glucose, total cholesterol, uric acid, triglycerides) drives localized market strategy.

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Global Compliance & Regulatory Certifications

HMD holds six international medical-device quality and regulatory certifications, ensuring compliance and supply continuity across major global markets:

MDSAP (Medical Device Single Audit Program)MDSAP (Medical Device Single Audit Program) 1 / 2
TFDA QMS Certification (Taiwan)
EN ISO 13485:2016 Medical Devices QMSEN ISO 13485:2016 Medical Devices QMS 1 / 2
Brazil ANVISA BPF (GMP for Class III IVD)Brazil ANVISA BPF (GMP for Class III IVD) 1 / 2
US FDA 21 CFR Part 820 (QMSR)US FDA 21 CFR Part 820 (QMSR) 1 / 2
EU IVDR (EU 2017/746)EU IVDR (EU 2017/746)EU IVDR (EU 2017/746)EU IVDR (EU 2017/746)EU IVDR (EU 2017/746)EU IVDR (EU 2017/746) 1 / 6

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Product information, partnership proposals, or any questions — we are here to help