KVALITO is a diverse company. Being a woman-owned business, we acknowledge equality and diversity in all our working...

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...
US and Chinese legislation US legislation What is the framework of US Legislation? Figure 1: Framework of FDA...
What types of risks are covered by Risk management? It covers the harms related to patients, users or/and environment....
What is Vigilance? It is a system for the notification and evaluation of incidents and Field Safety Corrective Actions...
Classification of software as a Medical device under Medical Device Regulation (European...
Temporary authorizations issued in response to the COVID-19 pandemic FDA enforces policy for infusion pumps and...
Some of the earliest known medical devices were being used in dental procedures between 7,500-9000 years ago in a...
Figure 1: Comparison of European and US Conformity Assessment process of Medical Devices. Adapted from European...
In response to the global pandemic of COVID-19, the FDA temporarily does not enforce supplier verification onsite...
2A Regulation shall be applied in its integrality in all the European Union. Unless a Directive is an objective...