AXSED医疗器械工业设计 -ENCN-

Medical Device Workstation Model & The Importance of Its Compliance Development

The compliance and agile parallelism is of great importance throughout the development process of medical devices. It includes the definition of product strategy, preliminary investigation of law and regulation, patent layout, usability engineering, user research innovation, the establishment of compliant and normative technique criterion, and how to meet the requirements of top-level design like quality management system and documentation, risk management and quality assurance, etc. All of these are the complex and systematically concurrent process. The quality assurance of products is on the basis of design. Its key is in the early-stage R&D of concurrent project.--AXSED agile compliance and quality system is willing to contribute to your success.

Medical Devices Require a Balance between Functionality and Operability

The comprehensive marketability of medical devices is required to strive a balance between its functionality and operability. It is a hard nut to crack. In fact, it is more like a compromise combing the consistent technical innovation, balanced measurement and art with the modern and human-centered design , which can also be regarded as the mutual impetus.--AXSED agile compliance and quality system is willing to contribute to your success.

Regulatory Layout and ISO13485 Quality Management System

  • acquisition, identification, marking, distribution and tracking of the external files.

  • stable provision of products meeting users’ demands and complying with relative regulations.

  • quality meets the standards.

  • allocation of resources and suitability.

  • conformity of management responsibility.

Risk Assessment and Document Control

  • The stage of planning: design and input the accurate information; analyze and evaluate the product life cycle of different periods.

  • The stage of design and development: usage management process; design management process; manufacture management process; storage risk management process.

  • The stage of preparation before marketing:Risk testing; verification; assurance; usability testing and clinical research.

Collection of all data and evidence.
Risk evaluation.
Meeting the requirements of marketing.

Quality Assurance and Top-Level Design

  • Compliance management shortens the R&D period.

  • Quality management system improves the products quality and enhances the customers’ satisfaction.

  • Risk management extends the life cycle of products.

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