Nanjing Leading Medical Technology Co., Ltd.

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Four-time certification—our foundation remains steadfast! Nanjing Leading Medical has once again earned the ISO 13485 quality management system certificate, marking its fourth consecutive achievement.

Recently, Nanjing Leading Medical Technology Co., Ltd. successfully obtained certification under the GB/T 42061-2022/ISO 13485:2016 quality management system for the fourth time and was awarded the corresponding certificate. This not only represents authoritative recognition of our quality management system’s ongoing compliance with international standards but also serves as a vivid testament to the company’s steadfast commitment to upholding high standards and pursuing excellence.

The scope of this certification comprehensively covers the company’s core business, including:

Research, development, manufacturing, and sales of antigens, antibodies, enzymes, and nanomicrospheres for in vitro diagnostic reagents;

Research, development, manufacturing, and sales of immunological reagents and rapid diagnostic reagents for infectious disease testing.

This marks Leading Medical’s capability to consistently and reliably deliver high‑standard, trustworthy products and solutions to global customers across the aforementioned fields.

ISO 13485 is the globally recognized gold standard for quality management in the medical device industry. It serves not only as a critical tool for organizations to achieve management excellence but also as the core engine driving continuous improvement. For Erli Ding Medical, adhering to this standard means:

Internally, it has systematically streamlined the end-to-end process from R&D to production, enhancing operational efficiency and product consistency.

Externally, it has earned us a trusted market reputation, built a robust brand moat, and provided an indisputable “passport” for us to thrive in global markets and serve international clients.

Four rounds of certification mark a milestone and, even more so, a new starting point. Taking this as an opportunity, Nanjing Leading Medical will continue to place quality first, delivering on its commitment to every customer through an even more robust system, more reliable products, and more satisfying services, thereby empowering the global diagnostics industry.

About Us

Leading Medical as R&D innovation hub and comprehensive solutions provider Always Focus Core technologies for diagnostic reagents, offering end-to-end technical solutions spanning the entire value chain—from raw materials to finished products. 。

1. Core Solution:

Comprehensive strategy for glycated hemoglobin (HbA1c) testing
Comprehensive methodological coverage: latex-enhanced immunoturbidimetric assay, enzymatic assay, and fluorescent lateral flow immunoassay.
Core raw materials are independently developed: monoclonal antibody oligomers, native glycated hemoglobin, and nanospheres.
Quality Control Product Closed Loop: HPLC Quality Control Product

2. Corporate Advantages:

All core raw materials are produced in-house and have been validated through a reagent platform, enabling an integrated solution that combines raw materials with manufacturing processes.

More than 60 key protein raw materials have been developed, with representative products including:

Natural glycated hemoglobin (HPLC/boric acid affinity chromatography/immunochromatography/biochemistry/specific protein assays/chemiluminescence, etc. platforms)
A leading domestic natural protein supplement series (covering lipid profiles, renal function, inflammation, diabetes, and more)
Globally exclusive technology for the production of HbA1c oligomer antibodies

More than 20 types of polymer materials have been developed, and eight patented technologies are held.

Biochemical latex microspheres: ranging from 60 nm - The particle size range accounting for nearly 90% of market demand, such as 300 nm.
Chromatographic colored microspheres: red, blue, black, etc.
Time resolution Fluorescence Microspheres: range up to 200 nm - 300 nm and other particle size ranges
Reagent development capabilities based on定向偶联 technology, with stable processes that are continuously refined.

Collaboration Model

Embark on a New Journey

In a highly competitive market, quality is the lifeblood of any enterprise, and ISO 13485 serves as a robust shield that safeguards this vital lifeline. Looking ahead, Leading Medical will place quality at the heart of its operations and use ISO 13485 as its guiding framework, continuously strengthening its capabilities, riding the waves of market dynamics, achieving sustainable growth, and steadily advancing toward an even brighter future!

Run, young dreamer!

There is a person who has paid more hardships than ordinary people. At work, the young man loves to specialize in research to meet difficulties, with full work enthusiasm, solid work style, as long as the product debugging needs, no matter how late, he will work overtime, never delay, the top of the night There is always his figure. He is a new employee in our sales department. Although he has a short entry time, he is proactive in his job and studies hard in experiments. In the experiment, we also have new thinking about the work; how to build the process of sales support work more perfect and transparent? It can make everyone better deal with it when the partner in charge of this work is away/when there is an emergency, and solve it calmly, so as to solve the problem for the customer as soon as possible. Life is a trek, only forward, not retreat. Perhaps walking, you will find that many things are not as simple as imagined, but what supports the non-stop pace is the dream of the guiding light! In the process of pursuing his dream, he has become more brave, and always firmly believes that as long as the dream is shining, the pace of progress will be solid and light!

2022-07-26

Welcome new colleagues to report!

This is a new colleague from our purchasing department. He studies business knowledge seriously in his work. He is quick in response, enterprising and lively and cheerful in personality. In the latest production scheduling, due to the shortage of a certain material on the production line, urgent scheduling was needed. She took the initiative to coordinate the matter. After various communications, she finally successfully scheduled the materials in place, making this production proceed smoothly!

2022-07-21