Embedded Files
EXPERIENCE
EXPERIENCE
Combination Products, Drugs and Biologics
Our expertise include developing and executing human factors strategies for combination products, drugs and biologics. Our innovative risk-based approach can identify and prioritize the critical programs that will require human factors planning and usability studies. We have capabilities and expertise in the following topics:
User research and contextual inquiries
Product design from feasibility to launch
Iterative prototyping and testing
Risk Analysis and HF Planning
Process and Templates for Use Related Risk Analysis (URRA)
Usability Testing and Validation
Regulatory Filing Support
Medical Devices
We have extensive experience and knowledge in designing, developing and testing medical devices including:
Defining user and product requirements
Prototyping and verification
Diagnostic systems development
Imaging and image analysis R&D
Hardware, software, firmware
Graphic user interface design
Human Factors user testing
Verification and Validation
Regulatory Compliance
We have extensive experience in planning and executing studies to meet the regulatory requirements of the FDA guidelines, EU MDR, IEC 62366 and requirements of various regions of Asia and Africa. We can help you assess your product in different phases of product development and collect data and documentation for submission to regulatory agencies including:
Human Factors Planning
Formative Studies
Summative Studies
Use Related Risk Analysis
FMEA
Risk Analysis Documentation
Contact us for a meeting to review our expertise and services
Contact support@seifion.com to get more information
Page updated
Google Sites
Report abuse