On August 21, 2020, TACRO Tech. together with Suzhou Medical Association and Shenzhen Medical Association, respectively held the "Training on Medical Software Production Quality Management Standards and Registration" in Suzhou and Shenzhen at the same time.

With the continuous development of IT technology and the continuous integration with medical technology, the application scenarios of medical software products are more and more extensive. As a special product with high technical requirements and difficult quality assurance in medical devices, the compliance development, product registration and quality system preparation of medical software are paid attention to.

Suzhou

Shenzhen

This training is aimed at R&D, registration and quality-related personnel of medical software-related development enterprises and scientific research institutes. It is carried out in Suzhou and Shenzhen on the same day, focusing on the two major themes of "Interpretation of the Appendix of Quality Management Standards for Medical Device Production: Independent Software and Guidelines for Field Inspection" and "Key Points for Writing Description Documents for Medical Device Software and Network Safety".Shi Guoqi, deputy general manager of Zhizhong Science and Technology, and Luowei, manager of TACRO Technology Regulations, served as lecturers in both places to interpret key clauses and guide implementation difficulties.

Suzhou,  TACRO Deputy General Manager Guoqi Shi

Shenzhen, TACRO Manager Wei Luo

After the training, the students came forward to ask the teachers one after another, and the teachers also answered.

It is believed that medical device manufactruer of software-related medical devices to better understand the relevant laws and regulations of medical software registration and production, and improve the regulatory compliance and quality control ability of products.