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Precision Medicine

Precision Medicine Precision medicine, also known as personalized medicine, is an approach to developing safer novel therapeutics that integrate genomics and big data (genetic, clinical, molecular, diagnostic and environmental data) to detect pathogenic events at the...

How is a system validated?

Definitions from ISO 9000:2005, revised by ISO 9000:2015 Quality management systems – Fundamentals and vocabulary.  AVerification: Confirmation, through the provision of objective evidence, that specified requirements have been fulfilled.Validation: Confirmation,...

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 form the software system. The software system, together with the packaging and the instruction for use, shape the software product....

Usability and Labelling

What is usability ?   The new Regulation, MDR, strengthens the rules regarding labelling and usability.   Usability is the characteristic of the user interface that facilitates use and establishes effectiveness, efficiency...