XPrecise (Beijing) Medical Technology Co., Ltd. (referred to as XPrecise), was established in Beijing on November 15th, 2022, as a large-scale manufacturer and service provider of medical radiotherapy equipment and systems. With a focus on the perfect integration of imaging and radiotherapy, XPrecise is an enterprise with advanced research and development capabilities in medical imaging and radiation therapy. The R&D team is composed of senior experts from well-known enterprises and institutions at home and abroad, with a technical staff comprising 80% professionals and over 30% graduate students. XPrecise has rich technical experience in the research and development of medical imaging and radiation therapy.
Radiotherapy technology has been developing for decades. Especially in recent years, medical imaging technology has made more and more contributions to the accuracy of radiotherapy. It is well known that traditional radiotherapy uses cone beam cone-beam computed tomography (CBCT) images for image guidance. However, CBCT is different from conventional CT in that its blurred and non-real-time image quality is difficult to meet the needs of the latest adaptive radiotherapy and other new clinical techniques. How to meet the clinical requirements for image quality has become a breakthrough in the development of radiotherapy equipment.
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Mr.
Li Zhaobin, the general manager, has ten years of experience as a hospital radiotherapy
physicist and ten years of management experience in technology, marketing, sales, and
other fields in overseas-funded enterprises. In 2016, he started as a co-founder and
established a medical linear accelerator R&D enterprise. During this period, he also
worked in the Department of Engineering Physics at Tsinghua University, responsible for
research and analysis of the industrialization of radiation oncology, promoting the
transformation of industry-university-research cooperation. He was hired as a senior
researcher by the Institute of Medical Physics and Engineering of the Department of
Engineering Physics. Now he is committed to leading XPrecise to become a high-tech
enterprise that independent researches and develops, produces, and sells medical linear
accelerators.
Mr. Cao Kai, chief Technology officer,
is a leader in the field of medical device Magnetic Resonance Imaging (MRI). With more
than 20 years of experience in R&D of medical products, he once served as the system
manager of a multinational enterprise’s Chinese magnetic resonance imaging. He
successfully transferred permanent magnet magnetic resonance production and R&D from
Japan to China and developed three magnetic resonance imaging products at the same time.
As a project manager, he led the project team to cooperate and develop superconducting
magnetic resonance products for the Chinese market.
QA Manager
Software Architect
Senior Electronics Engineer (EE)
Embedded Software Engineer (FPGA)
Senior Embedded Software Engineer
What are the general ideas and principles for the revision of the Measures for the Supervision and Administration of the Operation of Medical Devices (hereinafter referred to as the Measures)?
The Quality Management Standard for Clinical Trials of Medical Devices (Announcement No. 28, 2022, hereinafter referred to as the "Standard") has been issued and will come into force on May 1, 2022.
Recently, the State Pharmacovigilance Administration issued the Circular on the Implementation of GB 9706.1-2020 and Supporting Concurrent Standards and Special Standards (No. 14 of 2023, hereinafter referred to as the Circular).
What is the background of the Regulations on Supervision and Management of Enterprises' Implementation of the Main Responsibility for Quality and Safety of Medical Devices (hereinafter referred to as "the Regulations")?
What is the background of the revision of the Supervision and Administration of Medical Device Production" (hereinafter referred to as "the Measures") and the main ideas of the revision?
