About Ruihe

The R&D Center of Hebei Ruihe Medical Device Co., Ltd. has a R&D Department, Technology Department and Registration Department. It has a 3D printing laboratory, an Inspection And Testing Laboratory and a Microbiological Laboratory. It is committed to taking high-value medical consumables as the research core and comprehensively and systematically expanding in the direction of artificial intelligence, 3D printing and biological materials. It has been awarded with the Post-Doctoral Scientific Research Workstation, Hebei Enterprise Technology Center, Hebei Engineering Laboratory of Orthopedic Medical Implants and A-level R&D Institution of Industrial Enterprises in Hebei Province.

The Company brings in high-end talents in clinical medicine, materials science, mechanical design and other related disciplines to conduct research in artificial intelligence, 3D printing, biomaterials and other fields. It has established an industry, university and research cooperation mechanism with many key universities, scientific research institutions and hospitals to promote the transformation of scientific research achievements, set up research and development platforms to jointly break through key and common problems in the medical device industry, give impulse to the construction of a technology innovation system with enterprises as the main body, and develop capability of technologies and products with independent intellectual property rights.

The Company pays attention to the test process of product research and development, and has set up 3D Printing Laboratory, Inspection and Testing Laboratory and Microbiological Laboratory. The specific conditions of each laboratory are as follows:

1. The 3D Printing Laboratory introduced the Concept Laser Selective Laser Melting (SLM) 3D Printer from Germany, with a printing accuracy of 150 microns. The equipment can realize the design and manufacture of porous structures with different rod diameters. The three-dimensional mesh structure product formed by it is highly close to the pore size and porosity of trabecular bone structure, which can promote the growth of osteoblasts on the surface and in the voids of the product and elevate the bone fusion effect. The strength and elastic modulus of the product are matched with the cancellous bone. While enhancing the connection strength with the autogenous bone, it can effectively avoid and shield stress, make the product more attached and stable after implantation, and shorten the recovery period of the patient.

2. The Inspection and Testing Laboratory is introduced from the United States, Germany, Switzerland, Japan and other countries. It can implement high-precision tests, such as fatigue and static mechanical test, and curved surface and roundness measurement. By means of finite element analysis, metallographic microscopy test technology, static and fatigue test, study the relationship between raw material grade, structural properties, static mechanical properties, fatigue properties and corrosion resistance, establish standard operation methods for raw material performance analysis and evaluation, form material performance indicators that meet the product requirements of our Company, and ensure the suitability and reliability of material selection. Through the computer dynamic simulation test and analysis technology and the product safety and reliability test and evaluation technology, conduct a variety of research tests of the product, such as the static and dynamic fatigue test of the metal bone plate, the torsion, screwing in and out, pulling out force and self-tapping performance test of the metal bone screw, the fatigue test of the femoral stem neck of the hip joint, shank, tibial tray and femoral shaft, and the dynamic compression test of spinal column products, providing sufficient data support for the research and development of new products and technical improvement to ensure the safety and reliability of products.

3. The Microbiological Laboratory mainly includes the Microbial Limit Room, Sterility Test Room, Positive Control Room and relevant auxiliary experimental areas with 10000 level cleanliness, with the capability of microbial detection, such as initial contamination bacteria detection, sterility test, purified water microbial limit test and particulate pollution test.

The RD Center adheres to the multiple research and development paths of the combination of medicine and industry, cooperative development in related fields and independent research and development. The products and technologies cover the fields related to medical devices, such as spine, trauma, joints, sports medicine and equipment. At present, the key research work includes:

1. Covering the research, development and design of orthopedic medical devices, such as spinal column, trauma, joint and sports medicine, and forms technologies and products with independent intellectual property rights.

2. Being responsible for research, development and transformation of new materials, products, technologies and processes.

3. Cooperating with domestic and foreign universities, well-known experts and scholars to develop new products and technologies to better serve the clinic.

4. Improvement and promotion of existing products and technologies, transformation and evaluation of product trial production.

5. Development of customized products.

6. Product performance test and research, including FeA (finite element analysis), mechanical performance test, clinical simulation operation, etc.

On September 21, 2015, Ruihe Medical laid foundation and commenced the production, research and development projects

On January 16, 2016, formally completed the piling work of Ruihe Medical plant

On September 20, 2016, completed the main body capping work of Ruihe Medical plant

In June 2017, mobilized the first Tornas turning center equipment of Ruihe Medical on schedule

On April 28, 2018, Ruihe Medical officially settled in the office building of the new plant

On May 8, 2019, Ruihe Medical obtained the first medical device manufacturing license

On June 4, 2019, the School of Business Administration of Hebei University of Economics and Business signed a contract with Ruihe Medical School

In 2019, Ruihe Medical was rated as the Enterprise Technology Center of Hebei Province

In November 2019, Ruihe Medical passed the ISO9001 Quality Management System Certification

In December 2019, Ruihe Medical was rated as a High-Tech Enterprise

In December 2019, Ruihe Medical was awarded the Post-Doctoral Scientific Research Workstation

On July 1, 2020, Ruihe Medical party branch held the thematic party day activity to celebrate the 99th Anniversary of the Founding of the Communist Party

On August 5, 2020, a contract of “Yanshan University and Ruihe Medical Graduate Training Base” is officially signed and the Base was opened

In May 2021, Ruihe Medical participated in the 13th Annual Meeting of Orthopedists of CMDA (Chinese Medical Doctor Association)

In July 2021, Ruihe Medical won the bid (Group A) for the Procurement Project of Orthopedic Trauma Medical Consumables Alliance of 12 Provinces (Districts and Cities)

In September 2021, Ruihe Medical was rated as the Engineering Laboratory of Hebei Province

On April 20, 2022, Hebei Institute for Drug and Medical Device Control and Ruihe Medical established a Joint Laboratory for Collaborative Innovation and QS (Quality and Safety) Evaluation of Surgical Implant Devices