IEC 60601: Safety and effectiveness of medical electrical equipment. This standard specifies general requirements for basic safety and essential performance. Collateral standards apply the 60601-1-3 standard states for radiation protection in diagnostic X-ray...

First, the risk must be identified. It is always the same scheme; a hazard combined with a hazardous situation can lead to harm. All factors must be determined before the hazard occurs. Risks combine the severity of harm (S) and the probability of occurrence(O). A...

International standard IEC 62304 defines life cycle requirements for the development of medical software inside medical devices. This regulation is harmonized by the European Union and the United States and thereby serves as a standard by which to...

KVALITO is a diverse company. Being a woman-owned business, we acknowledge equality and diversity in all our working practices. We support our entire team to achieve success within their projects and their career development. After all, without excellent consultants,...