Definitions from ISO 9000:2005, revised by ISO 9000:2015 Quality management systems – Fundamentals and...
SMART Life Science
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...
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...
Good Documentation Practices in Regulated Environments
"Proper documentation is the only witness of what you have done: in its absence, you did nothing; if it is poor, you...
Digitalization of Pathology – A New Approach
Development and Validation of Digital Pathology Digital pathology means the use of technology to accelerate and...
Risk-Based Computerized System Validation (CSV) and Computer Software Assurance (CSA) – Old Wine in a New Bottle?
“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?
What is the development lifecycle of a Medical Device? Figure 1: Medical Device development lifecycle. Adapted from...
LIMS Implementation: Success Factors from a Project Manager Perspective
"Change before you have to." —Jack Welch A Laboratory Information Management System (LIMS) is software that allows...
Sterilization Processes for Medical Devices
What kind of sterilization methods can be used for a medical device? There are different methods...
CDRH Validation vs. CSV
“A goal without a method is nonsense.” — W. Edwards Deming What is CDRH Validation? In the USA, the FDA’s Centre for...
How to Overcome Validation Costs
“It is thrifty to prepare today for the wants of tomorrow.”–Aesop, Greek author (620 BC - 560...