Medical Device Development
Medical Device Development is a structured process for designing, testing, and commercializing medical devices, such as implants, diagnostic tools, or monitoring systems, that are used in healthcare. It involves interdisciplinary collaboration between engineers, clinicians, and regulatory experts to ensure safety, efficacy, and compliance with standards like ISO 13485 and FDA regulations. The process typically includes stages like concept development, prototyping, clinical trials, and post-market surveillance.
Developers should learn this methodology when working in healthcare technology, biotechnology, or medtech industries to create devices that improve patient outcomes and meet strict regulatory requirements. It is essential for roles involving hardware-software integration, such as developing wearable health monitors, surgical robots, or diagnostic imaging systems, where adherence to quality management systems and risk management is critical.