Introduction Nowadays, more and more companies start to grow and lose visibility of the organization’s global...

Introduction Nowadays, more and more companies start to grow and lose visibility of the organization’s global...
When FDA applies more advanced technologies to its work, stakeholders can explore new ways of developing FDA-regulated...
The quality and safety of a product have always been one of the biggest concerns in the pharmaceutical industry. To...
"Type designers are, at their best, the Stradivari of literature: not merely makers of saleable products,...
The pandemic lockdown has sped up digital transformation in this era. It is increasingly accepted that the...
“Intelligence is the ability to adapt to change.” (Stephen Hawking) Introduction To date, classical methodologies,...
Definitions from ISO 9000:2005, revised by ISO 9000:2015 Quality management systems – Fundamentals and...
A software product framework is a set of software units assembled in a software item. The collective software items...
What is usability ? The new Regulation, MDR, strengthens the rules regarding labelling and...
IEC 60601: Safety and effectiveness of medical electrical equipment. This standard specifies general requirements for...
First, the risk must be identified. It is always the same scheme; a hazard combined with a hazardous situation can...
International standard IEC 62304 defines life cycle requirements for the development of medical software...