EXPERIENCE
Combination Products, Drugs and Biologics (8 years)
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 (19 years)
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
Building Teams (12 years)
Extensive experience building successful engineering teams for large medical device and pharmaceutical companies. This included setting up the processes and procedures, hiring talent and managing the teams to support product launches.
Experience with building and managing:
Software verification teams
System verification and validation teams
Human factors teams
Contact us for a meeting to review our expertise and services
Contact support@seifion.com to get more information