Medical Device Manufacturing Quality, Safety, and Regulatory Training

The company-wide training session held by Jiutou Bird aimed to deepen employees' understanding of regulatory requirements related to the quality and safety of medical device production, as well as to ensure the thorough implementation of best practices in medical device manufacturing, registration, and management. This event showcased the company's commitment to excellence in medical device quality management and marked a significant step forward in strengthening its capabilities in this critical area.

The three core aspects of this training session not only underscore the company’s unwavering commitment to enhancing product quality and ensuring safety, but also highlight its forward-thinking approach and strong sense of responsibility in adhering to industry standards and regulations. Below is an in-depth analysis of these three key areas:

1. Strictly enforce the primary responsibility of medical device registration holders

Clearly defining responsibility boundaries: The training emphasized that, as the medical device registrant, the company is accountable for the entire product lifecycle—from design and development to manufacturing and post-market surveillance. This requires the company to establish a robust quality management system, ensuring that every step complies with relevant regulations and industry standards.

Enhancing Risk Awareness: Through case studies, regulatory insights, and other methods, we aim to strengthen employees' ability to identify and address potential risks, ensuring that issues are promptly detected and resolved during product design, production, and other critical stages—thereby reducing the likelihood of adverse events.

Strengthen internal oversight: Establish and improve a robust internal monitoring system, including regular audits and quality reviews, to ensure effective implementation of all regulatory requirements and enhance the company's overall compliance standards.

II. Effectively Strengthen the Registration Management of Contract Manufacturing for Medical Devices

Standardizing the outsourcing process: The training session provided a detailed explanation of the procedures, conditions, and requirements for contract manufacturing, clearly defining the responsibilities of both the commissioning party and the contractor to ensure that the outsourced production activities are legally compliant, high-quality, and fully controllable.

Strict Trustee Review: Emphasizes a rigorous examination of the trustee's qualifications, production capabilities, and quality management system to ensure they are fully equipped to undertake the entrusted production tasks and maintain product quality.

Strengthening Communication and Collaboration: The training encourages clients and contractors to establish a robust communication and collaboration framework, working together to address challenges in the production process and ensuring consistent, high-quality product performance.

3. Continuously strengthen supervision and management of contract manufacturing

Implement dynamic supervision: By establishing an information-based management system, we will monitor commissioned production activities in real time, promptly identifying and correcting any non-compliant behaviors to ensure the production process remains fully under control at all times.

Strengthen on-site inspections: Regularly organize site visits to the entrusted party to verify the effectiveness of their quality management system and ensure that production activities comply with regulatory requirements.

Establish a feedback mechanism: Create open and accessible communication channels to encourage employees, customers, regulatory bodies, and other stakeholders to actively report issues. Promptly implement corrective actions and continuously improve the management of contract manufacturing operations.

The management representative concluded by summarizing and analyzing typical, illegal cases of medical devices, providing insights from three key perspectives: the regulatory framework, comparisons between old and new regulations, and criminal liabilities. They highlighted specific issues present in relevant laws and past failure cases, while emphasizing the three critical mindsets we must embrace and strengthen—compliance awareness, quality awareness, and safety awareness. Additionally, they outlined requirements for relevant officials regarding daily supervision and inspection activities.

The successful conclusion of the JiuTouNiao Company's company-wide training session has laid a solid foundation for further enhancing the company's quality management of medical devices. Moving forward, the company will continue to uphold the philosophy of "walking the talk and taking immediate action," relentlessly strengthening internal processes and elevating product quality—ultimately delivering safer, more effective medical device solutions to patients.