Strengthen the Quality Management of Medical Devices and Build a Solid Defense Line for Medical Safety

In the medical device industry, product quality and compliance are undoubtedly the two core elements. As a leading product lifecycle management system in the industry, HAOSENsoft Aras PLM(hereinafter referred to as HSPLM). HSPLM provides comprehensive and efficient solutions for medical device enterprises. This article will share and explore with you how to help medical device enterprises accurately realize the requirements of ISO 13485 quality system, especially the key role it plays in core processes such as design history files (DHF) and equipment manufacturing records (DMR).

DHF Management

Help medical device enterprises build a complete recording system for traceability

With its excellent file management function, HSPLM system provides efficient and reliable Design History File (DHF) management solutions for medical device enterprises. During the product design stage, the system can record and track all key information in detail, including design files, specifications, verification and verification results, etc. to ensure that the design process strictly follows the ISO 13485 standard. In addition, the system also supports version control and approval process management to ensure the accuracy and consistency of design historical files, help enterprises easily conduct supervision review, and improve product quality and competitiveness.

DMR Management

Help medical device enterprises strengthen efficient compliance

In the critical stage of product manufacturing, the HSPLM plays an indispensable role to help medical device enterprises in efficiently managing equipment manufacturing records (DMR), ensuring that products strictly comply with quality standards and regulatory requirements, comprehensively tracking and recording all data and information related to product manufacturing, such as material lists, manufacturing instructions, and inspection records, providing solid data support for enterprises. Through a complete data traceability function, enterprises can access and review equipment manufacturing records at any time, ensuring that every manufacturing process meets standards and providing strong guarantees for product quality and compliance.

Quality Management Process

Comprehensively guarantee product quality

The HSPLM not only covers the management functions of Design History Files (DHF) and Equipment Manufacturing Records (DMR), but also includes tools such as CAPA and FMEA, thus constructing a comprehensive quality management system. Enterprises can significantly improve quality management efficiency, timely capture and correct potential problems, ensure that products comply with ISO 13485 standards, and lay a solid foundation for the stable development of the enterprise.

Continuous Improvement and Compliance Management

Deepen continuous improvement and strengthen compliance standards

In addition to strictly adhering to the ISO 13485 quality system standard, the HSPLM also supports enterprises in implementing continuous improvement and compliance management. This system can efficiently collect and analyze product data, accurately capture potential improvement space, and seamlessly integrate with the latest regulatory requirements to ensure that enterprise products always comply with industry standards, thereby winning the deep trust and satisfaction of customers.

HSPLM provides excellent quality and compliance solutions for medical enterprises in the medical device industry. It not only fully meets the requirements of ISO 13485 standard, ensuring product quality and compliance, but also provides continuous and powerful support for the stable development of enterprises, promoting the continuous progress and development of the medical device industry.

Domestic and Foreign Clients in the Medical Device Industry of Aras PLM