Category: Product development and processes

Health technology product development is a complex process where even a single wrong step can lead to significant delays, cost increases, or in the worst case, complete project failure. While the industry’s opportunities are enormous, health technology product development contains specific pitfalls that surprise too many companies. Let’s examine the five most common mistakes and methods to avoid them. One of the most serious errors in health technology product development is underestimating user needs. Too often, development teams focus on technical features while forgetting the everyday reality of actual users, such as nurses, doctors, or patients. This leads to products that may function technically flawlessly but do not integrate smoothly into the usage environment. Neglecting usability testing is particularly risky in health technology, as usage errors can compromise patient safety. The IEC 62366 standard requires systematic usability design and testing, but […]

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The development of medical software requires strict adherence to standards to ensure patient safety and meet regulatory requirements. The IEC 62304 standard defines comprehensive requirements for medical software lifecycle management, from design through maintenance. Health technology product development demands a deep understanding of these requirements so that the development process proceeds safely and efficiently. The IEC 62304 standard forms the foundation for safe medical software development. The standard ensures that software development follows a systematic approach where patient safety is at the center of every development phase. Compliance with the standard is not only a regulatory requirement, but it also serves as a quality assurance tool that minimizes errors and improves the reliability of the final product. The standard divides medical software into three safety classes based on their potential harm. Class A causes no injury or health hazards, Class B may cause […]

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Read More… from IEC 62304 standard requirements in medical software development