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DeviceLab’s Medical Device Development Process Step 6: Compliance & Regulatory Support
Posted on December 18, 2024 by DeviceLabBringing a medical device from concept to patients involves navigating a complex global landscape of ever-evolving regulations and standards. While daunting, regulatory requirements aim to ensure product safety, efficacy, and quality—building credibility with healthcare providers and patients. In this final section, we provide an overview of DeviceLab’s stepwise approach to integrating compliance into the entire […]
DeviceLab’s Medical Device Development Process Step 5: Human Factors and Usability
Posted on December 11, 2024 by DeviceLabMedical devices directly impact patient health and safety. Ensuring they are intuitive, easy to operate, and error-tolerant requires a human-centered design approach that deeply understands user needs and limitations. Human factors engineering and usability testing methodically identify use risks and validate solutions. In this section, we explore DeviceLab’s stepwise methodology to integrate user perspectives, mitigate […]