In the increasingly competitive medical device industry, Surgsci remains committed to the principle of “Quality First, Innovation Driven,” continually enhancing its R&D quality management capabilities.
From December 14 to 16, Surgsci held its 2024 Annual R&D Quality Management Training at the company headquarters. The training featured lectures from senior experts Mr. Wang and Mr. Zhuang from the Shenzhen Medical Device Quality Management Association, and saw active participation from the company’s R&D key personnel.
In his opening speech, General Manager Mr. Meng emphasized that medical device products are directly related to the health and lives of the people, and that the R&D team must always maintain a reverence for product quality. “Quality originates from design and is superior in production,” he remarked. Through systematic training and continuous practice, he highlighted the importance of transforming quality awareness into conscious team actions, driving the high-quality development of the enterprise.
Training Highlights
On the first day, the course focused on the “Design and Development Quality Management System Process,” providing an in-depth interpretation of regulatory requirements for medical device design and development. The training covered the key processes of the quality management system and explored the close connection between post-market supervision and design and development. Attendees were engaged, actively asking questions, and discussing specific issues encountered in practice with the instructors.
The second day’s theme was “Medical Device Risk Management.” The course systematically explained the core elements of risk management, particularly the application methods and implementation processes of DFMEA (Design Failure Mode and Effects Analysis). Discussions also covered how to integrate risk management concepts throughout the design and development process, helping attendees improve their ability to identify and control risks.
On the final day, the morning session focused on the “Registration and Certification Process.” The course systematically outlined the key steps of registration and certification, clarified submission requirements, and shared practical methods for integrating registration work into the R&D phase. The afternoon session focused on the medical device quality management system, providing detailed explanations of core audit requirements, further clarifying the direction and focus of R&D quality work.
Training Summary
After three days of intensive learning, participants gained a comprehensive understanding of the core knowledge and skills in R&D quality management. Through case studies and interactive Q&A sessions, they deepened their understanding of industry regulations, design and development processes, risk management, and registration and certification. The training concluded with a unique examination, fully assessing the participants’ learning outcomes.
The successful completion of this training highlights Surgsci’s strong emphasis on R&D quality management and its firm commitment to talent cultivation and team building. Continuous learning and improvement have further strengthened the professional capabilities of the R&D team, laying a solid foundation for future product innovation and quality enhancement. Surgsci is poised to contribute more wisdom and strength to the development of the medical device industry with safer and more efficient innovative products.
Future Outlook
Looking ahead, Surgsci will continue to uphold its “Quality First, Innovation Driven” R&D philosophy, intensifying internal training and talent cultivation to build a high-quality, professional R&D team. The company also aims to expand cooperation and exchange within and outside the industry, promoting the high-quality development of the medical device sector. Surgsci will remain customer-focused, continually innovating and making breakthroughs to drive progress in the medical device industry.