Definitions from ISO 9000:2005, revised by ISO 9000:2015 Quality management systems – Fundamentals and...

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...
KVALITO is a diverse company. Being a woman-owned business, we acknowledge equality and diversity in all our working...
"Proper documentation is the only witness of what you have done: in its absence, you did nothing; if it is poor, you...
Development and Validation of Digital Pathology Digital pathology means the use of technology to accelerate and...
“Discovering the unexpected is more important than confirming the known.” —George Box, Stuart Hunter, and William G....
What is the development lifecycle of a Medical Device? Figure 1: Medical Device development lifecycle. Adapted from...
"Change before you have to." —Jack Welch A Laboratory Information Management System (LIMS) is software that allows...
What kind of sterilization methods can be used for a medical device? There are different methods...
“A goal without a method is nonsense.” — W. Edwards Deming What is CDRH Validation? In the USA, the FDA’s Centre for...
“It is thrifty to prepare today for the wants of tomorrow.”–Aesop, Greek author (620 BC - 560...