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Topics | Services Offered |
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User-Centered Design | Understanding user needs and requirements, conducting usability testing and user research, designing intuitive user interfaces, incorporating human factors and ergonomics |
Regulatory Framework | Explaining FDA regulations and compliance, understanding ISO 13485 and CE marking, ensuring adherence to regulatory standards |
Risk Management in Medical Device Design | Identifying and assessing risks, developing risk mitigation strategies, incorporating risk management throughout the process |
Biocompatibility and Materials Selection | Selecting materials with biocompatibility properties, ensuring compatibility with human tissues, considering sterilization requirements |
Design for Manufacturing and Assembly (DFMA) | Optimizing manufacturing and assembly processes, designing for scalability and cost-effectiveness, streamlining production workflows |
Design Verification and Validation | Prototyping and testing medical device designs, evaluating device performance and safety, conducting verification and validation processes |
Human-Machine Interface | Designing intuitive and user-friendly interfaces, incorporating user feedback and usability principles, developing effective control mechanisms |
Emerging Trends in Medical Device Design | Exploring wearable medical devices and IoT integration, understanding advancements in telemedicine, incorporating AI and machine learning technologies |