It is vital to ensure the compliance during the period of medical devices’ development. It includes the components of product strategy, preliminary investigation and patent layout, user research and usability engineering, R&D of compliant and normative technology, satisfaction of QMS and documentation and the top level design of risk management and quality assurance.
Usability engineering service is based on the recent regulatory requirements of the international medical devices procedure, EU directives(2007/47/EG, 93/42/EWG, 98/79/EG), international usability or the standard of human factors project (62366-1:2015, IE62366:2007, IEC 60601-1-6, ANSI/AAMI HE74 and ANSI/AAMI HE75) and other relevant requirements of FDA.
AXSED human factors engineering service teams in German are dedicated to provide Chinese medical devices export enterprises with the relevant usability engineering documents to gain access to EU and the professional services before the R&D.
The professionals help the costumers with various work on analysis and research in the medical devices’ usability and offer customized schemes, which consist of demand analysis, process analysis and information construction, task analysis, function analysis, user analysis and innovation analysis, market analysis, the heuristic analysis and risk analysis.
AXSED provides customers with the service of setting usability standard according to the project:
Instruction.
Main Operability.
Perspective Goal.
Characteristics of Target Users.
Usability Standard.
Application Scene.
Formal Guide Creation.
Rules Made in Usability Design.
The Usability Scheme Phrase includes product design, interface design, and documentation.
Interface Information Architecture.
Interactive Scheme Design.
Layout Design.
GUI Design.
Product Design.
Process Design.
Communication between Production and Interface.
Integration of Technical Documents.
Compilation of Usability Process Documents.
Implement Formative Evaluation and form relevant documents according to the characteristics of the project and the state of R&D.
Connection with Subjects and Recruitment of Subjects.
Implementation and Documentation.
Usability Testing under Simulation Environment.
User Interview.
Focus-Group Discussion.
Expert Group with/without Subjects Monitoring.
Context System Analysis.
Bench Marking.
Heuristic Analysis.
Compliance Testing File.
We develop the final solutions of medical devices and provide the final detailed design depending on the specific needs of both the project and the customer.
Detailed Information Architecture.
Graphic Design of Product Interface.
Human-machine Interaction Design.
Optimum of Production and Cost Optimization.
Layout Detailed Inspection.
Product Prototype and Type Test Prototype.
Graphic Design of Detail Visualization.
Rapid Prototyping and Small Batch Planning.
Interactive Software Prototype.
Development Process Paralleling Usability Document.
Detailed Design of the Product.
Compilation of Introduction and Guidance.
For the validation of summative evaluation, we are responsible for recruiting qualified subjects home and abroad, formulating and implementing testing programs, and reporting the tests.
Recruitment of Compliant Subjects.
Organize and Implement Testing.
Compile Summative Documents and Interview Records .
Compile Compliant Testing Documents.
AXSED Human Factors Service Teams in German are dedicated to providing professional services for the usability documents required by Chinese exporters of medical devices to gain access to EU, as well as for previous R&D issues.
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