Drugdu.com expert's response:

The development process of a qualified medical device typically includes the following key steps:

Ⅰ. Preliminary Preparations

Business Registration: Register the company and clarify the business scope to prepare for future product production ranges and avoid subsequent changes.

Team Formation: Establish a professional and efficient R&D team, including talents in mechanical engineering, electrical engineering, software engineering, etc., to ensure the technical feasibility of the product.

Ⅱ. Product Development and Design

Product Requirement Determination: Conduct market research, clinical application scenario analysis, doctor visits, etc., by the product manager to clarify the product's functional requirements, performance requirements, and user expectations.

System Requirement Determination: Convert product requirements into engineering technical indicators, complete the division of system functional architecture and constituent components, and output related requirements for regulations and standards, risk and safety, usability, serviceability, and manufacturability.

R&D and Design: Based on system requirements, carry out structural design, sampling verification, and optimization iteration work for components. Simultaneously, formulate detailed testing plans and methods to ensure the accuracy and reliability of the design.

Ⅲ. Testing, Validation, and Type Testing

Testing and Validation: Conduct component testing, integration testing, system testing, regulatory testing, risk testing, usability testing, and internal animal experiments to verify whether the design of components and systems meets product requirements.

Type Testing: Ensure that the product complies with the requirements of relevant regulations and standards through type testing by the National Medical Products Administration (NMPA).

Ⅳ. Design Freeze and Production Preparation

Design Freeze: After passing the type testing, declare the design freeze and transfer controlled production-related documents such as BOM, material verification, and process SOP to the production department.

Production Preparation: Conduct design transfer work to convert components/systems from the R&D state to mass production status, conduct small-batch trial production, and prepare for clinical trials.

Ⅴ. Clinical Trials and Registration Certification

Clinical Trials: The produced prototypes need to complete clinical trial verification, including animal experiments, clinical trials, and clinical data analysis. Through clinical trials, confirm that the system's functions/performance meet clinical usage requirements.

Registration Certification: Submit clinical data and type testing reports, submit registration applications to the NMPA, and obtain medical device registration certificates after review and approval to allow the product to be marketed and sold.

Ⅵ. Continuous Improvement and Updates

Feedback Collection: After the product is launched, collect user feedback and clinical data to analyze the product's performance and safety.

Optimization and Improvement: Based on feedback and data, optimize and improve the product to continuously enhance its quality and user experience.

In addition, throughout the development process, attention should also be paid to product patent layout and intellectual property protection to ensure the product's uniqueness and market competitiveness. Meanwhile, comply with relevant regulations and standards to ensure the product's compliance and safety.

In summary, the development process of a qualified medical device is a complex and systematic process requiring collaboration among multiple departments and strict quality control. By following this process, the safety, effectiveness, and compliance of medical devices can be ensured, meeting the clinical needs of patients and regulatory requirements.