Usability Process: The Path to Safe Health Technology
The usability process in health technology development forms the foundation for safe and effective solutions. As medical devices and software become more deeply integrated into clinical work, their usability directly impacts patient safety and t…
The journey of health technology from innovation to market is a complex process that requires deep understanding of regulatory requirements, patient safety, and risk management. Product development in health technology differs significantly from other industries, as every stage from innovation to co…
The ISO 13485 standard specifies requirements for a quality management system (QMS) in organizations involved in the design, development, production, installation, and servicing of medical devices. It focuses on developing a robust QMS, comprehensive documentation, risk-based thinking, and continuou…
Internal auditing in accordance with ISO 13485 is a systematic and objective evaluation of how well an organization’s quality management system is functioning. It ensures compliance, identifies areas for improvement, and supports continuous improvement within a health technology company. The audit p…
Excluding risk class I devices, notified body auditing is an essential process in the health technology field, where a third party evaluates a company’s quality system and documentation for compliance with MDR requirements. The most common challenges relate to documentation management, deficiencies …
A Quality Management System (QMS) is an essential framework for medical devices that ensures product safety and compliance with regulatory requirements. It encompasses documented processes, risk management, and continuous improvement methods. A functioning QMS is a prerequisite for CE marking and ma…
What is formative testing?
Formative testing is continuous evaluation during product development. Its goal is to identify problems and improve the user experience as the development process progresses. In health technology, this means regular usability testing with prototypes and development versio…
When is CE marking mandatory for medical devices?
CE marking is mandatory for all medical devices placed on the EU market that fall within the scope of the Medical Device Regulation (MDR). The marking demonstrates that the device meets safety and performance requirements. The only exceptions are cu…
Clinical evidence for the EU market refers to scientific proof of a health technology product’s safety and efficacy in accordance with the MDR regulation. Requirements vary by device risk class and may include clinical investigations, literature reviews, or the use of existing real-world data. To ob…
