The term "theranostics" is a combination of "therapy" and "diagnostics"; it is an emerging field that combines into a...
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How Web and Mobile Applications as Medical Devices are Transforming Healthcare Delivery: Trends and Predictions
Introduction Mobile Health (M-Health) technology, using mobile devices like smartphones and tablets, has been rapidly...
Why is Data Integrity the Base of Digital Health?
Over the past century, advances in nutrition and medicine have contributed to a rise in life expectancy. However, as...
Agile and Scrum in GxP Environments – How does it Work in Practice?
“Intelligence is the ability to adapt to change.” (Stephen Hawking) Introduction To date, classical methodologies,...
Precision Medicine
Precision Medicine Precision medicine, also known as personalized medicine, is an approach to developing safer novel...
How is a system validated?
Definitions from ISO 9000:2005, revised by ISO 9000:2015 Quality management systems – Fundamentals and...
What is a software product framework?
A software product framework is a set of software units assembled in a software item. The collective software items...
Usability and Labelling
What is usability ? The new Regulation, MDR, strengthens the rules regarding labelling and usability. Usability is...
Electrical Safety and EMC 60601
IEC 60601: Safety and effectiveness of medical electrical equipment. This standard specifies general requirements for...
How to conduct a Software Risk Assessment
First, the risk must be identified. It is always the same scheme; a hazard combined with a hazardous situation can...
What is Software of an Unknown Provenance known as SOUP?
International standard IEC 62304 defines life cycle requirements for the development of medical software...
Quality as a Driver in Organizations
KVALITO is a diverse company. Being a woman-owned business, we acknowledge equality and diversity in all our working...